SafeCare Standards Word Version
SafeCare Standards Word Version
TABLE OF CONTENTS
HEALTH CARE ORGANISATION MANAGEMENT 5
SE 4 Management of Information 25
SE 5 Risk Management 33
CARE OF PATIENTS 39
SE 7 In-patient Care 51
SPECIALISED SERVICES 59
SE 9 Laboratory Services 67
SE 11 Medication Management 81
ANCILLARY SERVICES 87
SE 13 Support Services 95
At the governance level there is an entity, i.e. a state health department, provincial authority or local
authority, responsible for directing the operation of the community health facility service and
accountable for providing a quality service to the population that seeks care. The responsibilities of
the governing authority lie primarily in providing systems, guidelines and resources, to enable the
health facility personnel to reach their objectives. It is the responsibility of the national body to define
what services are required to best meet the health needs of the community. The provinces and local
government define how these services are to be implemented by the community health facility
services.
Direction of the provision of services is provided from district or regional level. Managers at this level
ensure that centralised expertise is provided to support the personnel of community health facility
services in all their activities. This is provided through visits, written communication, monitoring and
education.
The lines of responsibility and accountability are documented, and are made easy to follow by being
depicted in an organogram. The structure of the health facility depicts all established posts, and
explains the lines of accountability for each post incumbent. The personnel in the service need to
know how these lines of accountability work, both within the service and up to the Chief Executive
Officer level.
At the service level, a manager is appointed for day-to-day management. He or she ensures, that the
policies of the governing authority are implemented, and that policies and procedures, appropriate to
the specific service, are developed and implemented. The responsibilities of this manager are
documented and are known to the personnel of the service.
While managers are appointed to posts in the health service, the community health facility also
identifies persons who take leadership roles, such as senior nurses. These leaders take responsibility
for forming teams, which ensure quality in all aspects of patient care. This can usually be done without
additional resources, but it does lead to the improved use of existing resources.
The leaders are recognised and brought into the process of defining the health service's mission.
Based on that mission, they work collaboratively to develop the plans and policies needed to fulfil the
mission and to co-ordinate and integrate the health service's activities.
The lines of communication for achieving these goals are represented on a health facility chart. The
health facility structure includes all members of the health service, including those persons at the
governing level, to whom the managers have lines of responsibility and accountability. Documents
prepared by each healthcare service define their goals and identify current and planned services.
The managers of each healthcare service make their human resources and other resource
requirements known to the governing authority. This helps to ensure that adequate human resources,
space, equipment and other resources are available to meet patients needs at all times.
The service manager is accountable for the cost-effective use of resources.
Standards
It is important that the health facility has clear leadership, operates efficiently, and provides quality
healthcare services. The lines of communication for achieving these goals are presented in an
organisational chart or other document.
The responsibilities of governing bodies lie primarily in approving plans and documents submitted by
the managers of the health facility. Those elements of management requiring approval by governance
are documented.
1.1.1 Criteria
1.1.1.1. Documents describe governance accountability and responsibilities.
1.1.1.2. There is an organisational chart or document, which describes the lines of authority and accountability
from governance and within the service.
1.1.1.3. The responsibilities of governance include providing support to the personnel in the health facility.
1.1.1.4. The support from regional or district managers includes regular supervisory visits, monitoring, written
communications and education.
1.1.1.5. The facility has a valid licence, issued by an acknowledged healthcare licensing authority, to operate
as a healthcare facility.
1.1.1.6. This license covers all services offered by the facility.
1.1.1.7. The pharmacy is licensed by the country's pharmacy council or equivalent body.
1.1.1.8. The laboratory is licensed by the country's laboratory council or equivalent body.
1.1.1.9. The diagnostic imaging service is licensed by the country's radiation control council or equivalent
body.
1.2.1 Criteria
1.2.1.1. The facility manager position has been filled for the past year.
1.2.1.2. The facility manager manages the day-to-day operation of the service.
1.2.1.3. The facility manager has the education and experience to carry out his or her responsibilities.
1.2.1.4. The facility manager ensures that approved policies are carried out.
1.2.1.5. The facility manager ensures compliance with applicable Laws and Regulations.
1.2.1.6. The facility manager implements processes to manage and control human, financial and other
resources.
1.2.1.7. Contracts and other arrangements are monitored to ensure that the terms of the contracts are met.
1.2.2. Budgeting, reporting and auditing processes are consistent with statutory
requirements and accepted standards.
Intent of 1.2.2
A standard method of accounting and reporting is essential for efficient delivery of quality health care.
Efficient, cost-effective and sustainable service delivery depends upon having up-to-date and
accurate financial accounts. A budgeting process results in a defined method of allocating resources.
Financial planning and management needs to be conducted by a person who is suitably qualified and
experienced in all matters relating to the health facility's finances. This person must be able to identify
financial constraints and possibilities and be able to respond by developing accurate policies or
procedures. This person must also be able to advise on how much, what and when to invest as a
result of a thorough analysis of plans. Clinical and other leaders need to be included in planning their
financial requirements. They also require information relating to the funds available to them for
managing their departments, and up-to-date statements of current expenditure. Sound accounting and
auditing practices are implemented to ensure transparency.
1.2.2 Criteria
1.2.2.1. There are written policies and procedures for accounting functions.
1.2.2.2. The accounting function is performed by an individual with appropriate training and experience.
1.2.2.3. The qualified accounting personnel ensure that policies and procedures are available to guide all the
personnel and that they are implemented.
1.2.2.4. There are written policies and procedures for maintaining internal and external financial audit systems
that meet audit requirements.
1.2.2.5. There are written policies and procedures for the payment of creditors.
1.2.2.6. There is a budgeting process.
1.2.2.7. The budgeting process is prepared in a timely manner and is used for expenditure tracking.
1.2.2.8. There is an asset register, which is routinely maintained.
1.2.2.9. There is an inventory, which is checked according to policy.
1.2.2.10. There is a mechanism for ensuring that the level of debtors is kept to the minimum.
1.2.2.11. There is an effective system for invoicing and billing patients for healthcare services rendered, which
includes data quality checks.
1.2.3. The health facility's clinical and managerial leaders are identified and are
collectively responsible for creating the plans and policies needed to fulfil the mission.
Intent of 1.2.3
While managers are appointed to posts and have a leadership role, leaders of a health facility may
arise from many sources. These leaders may represent every service in the health facility, e.g.
medical, nursing, maintenance, administration, physiotherapy and radiography. Leaders may also be
nominated or elected to certain committees, i.e. health and safety committees and infection control
committees. Effective leadership is essential for a healthcare health facility to be able to operate
efficiently and fulfil its mission. Leadership is given to the organisation by individuals working together
and separately and can be provided by any number of individuals.
Leaders may have formal titles, or be informally recognised for their seniority, stature, or contribution to
the health facility. It is important that all the leaders of a health facility are recognised and brought into
the process of defining the health facility's mission. The leaders work collaboratively to develop the
plans and policies needed to fulfil the mission.
1.2.3 Criteria
1.2.3.1. A senior management team is responsible for operating the facility.
1.2.3.2. The facility's clinical leaders are identified and are collectively responsible for creating plans to fulfil
the organisation's mission.
1.2.3.3. The leaders are collectively responsible for ensuring that the mission statement is known to all
personnel, patients, carers and the community served.
1.2.4. The health facility manager plans for the type of services required to meet the
needs of the patients served by the facility, in consultation with community members
and/or stakeholders.
1.2.4 Criteria
1.2.4.1. The health facility manager promotes networking with the leaders of other relevant organisations in
the community.
1.2.4.2. There is evidence of meetings with representatives of the community.
1.2.4.3. Community leaders (including traditional healers where appropriate) are represented.
1.2.4.4. The facility is aware of and accesses services from other provider facilities operating in the area.
1.2.5. The health facility's leaders ensure that policies and procedures are
implemented to support the activities of the health facility and to guide the personnel,
patients and visitors.
Intent of 1.2.5
Policies and procedures are formulated at different levels of authority, e.g. national Acts and
regulations, national health and labour departmental policies, regional policies and health facility
policies.
Leaders must ensure that all policies applying to the health facility are available to the personnel, and
that they are implemented and monitored as they relate to various departments, services and functions
. Leaders should ensure that policies and procedures are available to guide the personnel in such
matters as allocation, use and care of resources, financial practices, human resource management
and dealing with complaints from patients and visitors.
The availability and application of specific policies and guidelines will be assessed and measured in
the relevant services, e.g. midwifery.
1.2.5 Criteria
1.2.5.1. The health facility's manager ensures that policies and procedures guide and support the activities
and management of the health facility.
1.2.5.2. A designated staff member is responsible for compiling and indexing policies and procedures, and
ensuring their circulation, recall and review.
1.2.5.3. Policies and procedures are signed/endorsed by persons authorised to do so.
1.2.5.4. Policies and procedures are compiled into a comprehensive manual, which is indexed and easily
accessible to all staff members.
1.2.5.5. All policies and procedures are reviewed at appropriate intervals, dated and signed.
1.2.5.6. There is a mechanism for ensuring that policies are known and implemented.
1.2.6. The organisation ensures that supplies and provisions are ordered, received,
safely stored and provided to departments in time to meet their needs.
1.2.6 Criteria
1.2.6.1. A suitably qualified individual is designated to control the ordering, storage, distribution and control of
equipment and supplies used in the organisation.
1.2.6.2. There is a system for ensuring that equipment and supplies are ordered, available, correctly stored
and distributed.
1.2.6.3. A list of approved suppliers is available.
1.2.6.4. There is a system for monitoring the quality of goods delivered.
1.2.6.5. There is a system for monitoring the use of resources and taking corrective actions when required.
1.2.6.6. Secure adequate storage facilities are available.
1.2.6.7. Records are kept of goods received and goods issued.
1.2.6.8. The "first expired first out" principle is applied to avoid out dated stock.
1.2.6.9. There is a system for disposing of expired stock, including pharmaceuticals.
A comprehensive approach to quality management and improvement includes the following processes:
These processes, when performed well, provide the framework for the health facility and its leaders to
achieve the objective of providing quality patient care in a safe, well-managed environment.
The continuous monitoring, analysing and improving of clinical and managerial processes must be well
organised and have clear leadership to achieve maximum benefit.
The framework presented in the COHSASA standards is suitable for a wide variety of structured
programmes, and less formal approaches to quality management and improvement. This framework
can also incorporate traditional monitoring programmes such as those related to unexpected events
(risk management) and resource use (utilisation management).
Well-designed processes or services draw on a variety of information sources. Good process design:
A primary responsibility of leaders is to set priorities. Health facilities typically find more opportunities
for quality monitoring and improvement than they have human and other resources to undertake.
Therefore, the leaders provide focus for the organisation's quality monitoring and improvement
activities. The leaders prioritise those critical, high-risk or problem-prone processes that most directly
relate to the quality of care and the safety of the environment. The leaders use available data and
information to identify areas that must be prioritised.
1.3.1 Criteria
1.3.1.1. There is a relevant training programme to equip the personnel with the necessary competencies for
designing, implementing and evaluating a quality management and improvement programme.
1.3.1.2. The health centre's manager and personnel collaborate to plan and carry out the quality improvement
and patient safety programme.
1.3.1.3. The health centre's manager and personnel monitor the quality data collected by the institution.
1.3.1.4. The health centre's manager and personnel design new and modified systems and processes
according to quality improvement principles.
1.3.1.5. The quality management and improvement programme reflects the scope of service delivery in
relation to managerial, clinical and support services.
1.3.1.6. The quality management and improvement programme reflects all components and quality activities
in relation to standard/indicator development, monitoring/evaluation and remedial action.
1.3.1.7. There is a process for reviewing patient care.
1.3.1.8. There is a process for reviewing medication use.
1.3.1.9. There is a process for monitoring patient satisfaction with the care process, the care environment and
the facility's personnel.
1.3.1.10. There is a relevant/appropriate system for reporting on quality management and improvement matters
and communicating with all stakeholders concerned.
The health facility uses appropriate resources and involves those individuals, disciplines, and
departments closest to the processes or activities to be improved. Responsibility for planning and
carrying out improvement is assigned to individuals or to a team. Any needed training is provided and
information management or other resources are made available.
Once a change is planned, data is collected during a test period to demonstrate that the change is
actually an improvement. To ensure that the improvement is sustained, monitoring data is then
collected for ongoing analysis. Effective changes are incorporated into standard operating procedures
and any necessary education of the personnel is carried out. The health facility documents those
improvements achieved and sustained as part of its quality management and improvement processes.
1.3.2 Criteria
1.3.2.1. The organisation documents the improvements achieved and sustained.
1.3.2.2. This information leads to the development of processes to ensure that quality is sustained.
Recruiting, evaluating and appointing personnel are best accomplished through a co-ordinated,
efficient and uniform process. It is usual for this to be done at a central point. It is also essential to
document an applicant's skills, knowledge, education and previous work experience. It is particularly
important to carefully review the credentials of medical and nursing personnel because they are
involved in clinical care processes and work directly with patients.
Individual staff members have their responsibilities defined in a current job description. The job
description is the basis for assignment, orientation to their work, and evaluation of how well they fulfil
their job responsibilities. Consultant personnel have their responsibilities defined in contract
agreements.
Healthcare facilities should provide their personnel with opportunities to learn and advance personally
and professionally. Thus, in-service education and other learning opportunities should be offered to
them.
Standards
2.2.2. Each staff member's responsibilities are defined in a current job description.
Intent of 2.2.2
Individual staff members have their responsibilities defined in a current job description.
The job description/performance agreement provides details of accountability, responsibility, formal
lines of communication, principal duties and entitlements. It is a guide for an individual in a specific
position within an organisation. Key performance areas should be included in order to evaluate the
staff member's performance.
2.2.2 Criteria
2.2.2.1. Each employee has a written job description/performance agreement, which defines their
responsibilities.
2.2.2.2. Each staff member signs their job description/performance agreement to show that that they accept it.
2.2.2.3. Job descriptions/performance agreements are reviewed according to organisational policy.
2.2.3. The health facility uses a defined process to evaluate the knowledge and skills
of personnel to ensure that these are consistent with patient needs.
Intent of 2.2.3
The health facility defines the process for and the frequency of the ongoing evaluation of the abilities
of the personnel. Ongoing evaluation ensures that training occurs when needed and that the
personnel member is able to assume new or changed responsibilities. While such evaluation is best
carried out in an ongoing manner, there is a least one documented evaluation each year for each
personnel member.
2.2.3 Criteria
2.2.3.1. The staff member's registration, education, training and experience are used to authorise the
individual to provide clinical services consistent with his/her qualifications.
2.2.3.2. There is at least one documented appraisal of each staff member each year or more frequently as
defined by the health facility.
2.2.3.3. New personnel members are evaluated as determined by organisational policy.
2.3. Credentialing
2.3.1. There is an effective process for gathering, verifying and evaluating the
credentials (registration, education, training and experience) of those health care
professionals who are permitted to provide patient care without supervision.
Intent of 2.3.1
Healthcare professionals who are registered to provide patient care without clinical supervision are
primarily responsible for patient care and care outcomes. These professionals usually include doctors,
dentists, professional nurses, radiographers, and members of other professions allied to medicine. The
health facility needs to ensure that it has qualified health professionals, who appropriately match its
mission, resources and patient needs.
Evaluating an individual's credentials is the basis for two decisions: whether this individual can
contribute to fulfilling the organisation's mission and meeting patient needs, and, if so, what clinical
services this individual is qualified to perform.
These two decisions are documented, and the latter decision is the basis for evaluating the individual's
ongoing performance.
2.3.1 Criteria
2.3.1.1. There is a process for evaluating and verifying the credentials (licence, education, training and
experience) of physicians.
2.3.1.2. There is a process for evaluating and verifying the credentials (licence, education, training and
experience) of nurses and other health professionals.
2.3.1.3. The registration, education, training and experience of these individuals are documented.
2.3.1.4. A determination is made about the annual registration of the individual to provide patient care
services.
It is important to orientate and induct all doctors. Contract workers and volunteers are also orientated
to the health facility and their specific assignment or responsibilities, such as patient safety and
infection control.
2.4.1 Criteria
2.4.1.1. There are written programmes for orientating and inducting personnel to the health facility.
2.4.1.2. Contract workers and volunteers are orientated to the health facility, their job responsibilities and their
specific assignments.
2.4.2. Each staff member receives on-going in-service education and training to
maintain or advance his/her skills and knowledge, based on identified needs.
Intent of 2.4.2
The health facility has a responsibility to ensure that the personnel are educated in matters that affect
their functioning in the specific health facility. In particular, the personnel are trained in health and
safety matters, infection control and cardiac life support. The health facility also collects and integrates
data from several sources to understand the ongoing educational needs of the personnel. Such
sources include monitoring data from the facility management programme, the introduction of new
technology, skills and knowledge areas identified through the review of job performance, new clinical
procedures, and future plans and strategies of the health facility.
Education is relevant to each staff member as well as to the continuing advancement of the health
facility in meeting patient needs and maintaining acceptable performance, teaching new skills, and
providing training on new equipment and procedures. There is documented evidence that each staff
member who has attended training has gained the required competencies.
2.4.2 Criteria
2.4.2.1. The health facility has a co-ordinated plan for in-service education.
2.4.2.2. The health facility uses various sources of data and information to identify the in-service
training/education needs of the personnel.
2.4.2.3. All health facility personnel are provided with on-going in-service education/training.
2.4.2.4. Personnel competencies, where relevant, are assessed and recorded after in-service
training/education.
Patient care outcomes are improved when patients, and, as appropriate, their families or those who
make decisions on their behalf, are involved in care decisions and processes in a way that matches
cultural expectations.
To promote patient rights in a health facility, one starts by defining those rights, followed by educating
patients and the personnel about those rights. Patients are informed of their rights and how to act on
them. The personnel are taught to understand and respect patients' beliefs and values and to provide
considerate and respectful care, thus protecting the patients' dignity.
How these processes are carried out in a health facility depends on its country's laws, regulations and
charters and any international conventions, treaties or agreements on human rights endorsed by that
country.
In order to meet the community's needs for services, the health facility has to clearly define the
boundaries of the community, and the boundaries of the services provided by the health facility.
Service managers are competent in defining these geographic areas and assessing the social and
healthcare needs of their inhabitants. Equitability and availability of service provision are assisted
through community participation.
Patients and their families need complete information on the care and services offered by the health
facility as well as how to access those services. Providing this information is essential to building open
and trusting communication between patients, their families and the health facility. Such information
helps match the patient's expectations with the ability of the health facility to meet those expectations.
Information on alternative sources of care and services is provided, when the needed care is beyond
the health facility's mission and capabilities.
The service provides co-ordination with other services in the district, and ensures that patients are
appropriately referred to the services, that meet their ongoing care needs. All patients are referred to
the next level of care, when their needs fall beyond the scope of clinic personnel competence.
Patients who need additional health or social services are referred appropriately. Guidelines are
available for patient referral.
Standards
Patient and family rights are a fundamental element of all contacts between the personnel of a health
facility and patients and families. Thus, policies and procedures are developed and implemented to
ensure that all staff members are aware of and respond to patient and family rights issues, including
their role in supporting the right of patients and families to participate in the care process.
Admission to a health facility can be a frightening and confusing experience for patients, making it
difficult for them to understand and act on their rights. Thus, the health facility prepares a written
statement of patient and family rights, and this is given to patients when they enter the health facility
for care, and is available throughout their stay. For example, the statement may be displayed as a
poster in the facility. The statement is appropriate to the patient's age, understanding and language.
When written communication is not effective or appropriate, the patient and family are informed of their
rights in a manner they can understand.
3.1.1 Criteria
3.1.1.1. Organisational policy regarding patient and family rights is implemented.
3.1.1.2. Where applicable, relevant charters, laws and regulations are included in organisational policies
regarding patient and family rights.
3.1.1.3. The personnel are trained on the policies and procedures and their participation in care processes.
relationships. Such information can be misused by the personnel of the health facility, family member,
or others not authorised to have access to the information.
3.2.1 Criteria
3.2.1.1. The patient's need for privacy is protected during all examinations, procedures and treatments.
3.2.1.2. The patient's need for privacy is protected when providing personal information.
3.2.1.3. The patient's right to privacy is protected for all forms of counselling.
3.2.1.4. Policies and procedures to prevent the loss or misuse of patient information are implemented.
3.2.1.5. The policy includes the right to confidentiality of patient records.
about patient care, and the patient's right to participate in those processes.
Intent of 3.5.1
Patients have a right to voice complaints about their care, and to have those complaints reviewed and,
where possible, resolved. Also, decisions regarding care sometimes present questions, conflicts or
other dilemmas for the health facility and the patient, family or other decision-makers. These
dilemmas may arise around issues of access, treatment or discharge. The health facility has
established processes for seeking resolutions to such dilemmas and complaints. The health facility
identifies in policies and procedures those who need to be involved in the processes and how the
patient and family participate.
3.5.1 Criteria
3.5.1.1. There is a mechanism to allow complaints to be heard and acted upon.
3.5.1.2. Patients are aware of their right to voice complaints and the processes by which to do so.
3.5.1.3. Complaints are recorded, evaluated and analysed.
personnel will be trained to communicate with the hard of hearing, and translation services will be
available for those who speak foreign languages. Mechanisms for meeting these needs will be
documented and known to the personnel.
3.7.1 Criteria
3.7.1.1. The health facility renders services based on the needs of the population, but at least for eight hours
a day, five days a week.
3.7.1.2. The health facility has access to Ambulance Services (EMS).
3.7.1.3. There are appointment systems, where appropriate.
3.7.1.4. Patients who are waiting are advised of any delays that may be experienced in receiving attention.
3.7.2. Measures are in place to ensure that patient access to the facility is facilitated
by adequate infrastructural arrangements.
3.7.2 Criteria
3.7.2.1. There is an access road to the facility.
3.7.2.2. The condition of the road does not restrict patients in reaching the facility (e.g. traffic, road works,
safety, ambulance access).
3.7.2.3. The road is accessible throughout the year (e.g. take a situation like the rainy season into account).
3.7.2.4. Direction signs to the facility are clearly readable and up to date.
3.7.2.5. A telephone / emergency number is available.
3.7.2.6. The name of the organisation and its purpose is clearly indicated on the site.
3.7.2.7. Parking is made available close to the building entrance for patients, including the physically
challenged.
3.7.2.8. There is wheelchair access to and within the building.
3.7.2.9. Ramps and stairs include safety features such as rails.
3.7.2.10. Directions to the different departments are clearly indicated.
During the entry process, patients and their families receive sufficient information to make informed
decisions about seeking care. Information is provided on proposed care, the expected results, and
any expected cost to the patient or family for that care, when this is not paid for by a public or private
source. Patients and families need complete information on the care and services offered by the
health facility and on how to access those services. Providing this information is essential to building
open and trusting communication between patients, families and the health facility. This information
helps to match the patient's expectations to the ability of the health facility to meet those expectations.
Information on alternative sources of care and services is provided, when the needed care is beyond
the health facility's mission and capabilities.
For patients and families to participate in care decisions, they need basic information regarding the
medical condition, found during assessment and on the proposed care and treatment. Patients and
families understand when they will be given this information and who is responsible for telling them.
Patients and families understand the kinds of decisions that must be made about care and how to
participate in those decisions. In addition, patients and families need to understand the health
facility's process for obtaining consent and which care processes, tests, procedures and treatments
require their consent.
While some patients may not wish to personally participate in the decisions regarding their care, they
are, nevertheless, given the opportunity, and can choose to participate through a family member,
friend or a surrogate decision-maker.
3.8.1 Criteria
3.8.1.1. Patients are given information about the care and services provided by the health facility.
3.8.1.2. Information is provided in a way and in a language that is understood by those making the care
decisions.
3.8.1.3. Information on services, hours of operation, and processes for obtaining care is provided to agencies
and referral sources in the community, and to the population served.
4.Management of Information
Each service determines its information requirements for improving managerial and clinical care.
Objectives are set for each programme, and information is required to ensure that these objectives are
met.
Required levels of security and confidentiality are applied. An effective process defines who has
access to information, the information to which an individual has access, the user's obligation to keep
information confidential and the process followed when confidentiality and/or security are violated.
The service develops a policy to authorise such individuals and identifies the content and format for
entries into patient records. There is a process for ensuring that only authorised individuals make
entries in patient records.
The service's information management plan, once complete and approved, is implemented. The
health facility provides the staff, technology and other resources necessary to implement the plan and
meet the identified information needs of the healthcare providers, managers and others. The
management ensures that the personnel have the supplies, registers, check lists, forms, etc required
for data management.
Those individuals in the health facility who generate, collect, analyse and use data and information are
educated and trained to participate effectively in the management of information and to understand the
need for security and confidentiality of data and information.
Aggregated data provides a profile of the service over time and allows the comparison of its
performance improvement activities. In particular, aggregated data from patient visits and treatment
provided (e.g. immunisations) can help the health facility understand its current performance and
identify opportunities for improvement. Data is used for utilisation review and for analysing costs per
patient.
By participating in external performance databases, a health facility can compare its performance to
that of other similar health facilities, locally or nationally. Performance comparison is an effective tool
for identifying opportunities for improvement and documenting the service's performance level.
The information management process makes it possible to combine information from various sources
and generate reports to support decision-making. In particular, the combination of clinical and
managerial information supports the leaders of the health facility to plan collaboratively. The
information management process supports leaders with longitudinal and comparative data. Service
managers and leaders use this data to improve the quality of the services offered.
The clinical record of each patient needs to contain sufficient information to support the diagnosis,
justify the treatment provided, and document the care given. Where carry cards are used, there are
summaries of each attendance in the service, which will provide this information. A standardised
format and content of a patient's record will help promote the integration and continuity of care among
the various providers of care to the patient, and the health facility determines the specific data and
information recorded in the clinical record.
Uniform use of diagnostic and procedure codes supports data aggregation and analysis.
Abbreviations and symbols are also standardised. Such standardisation is consistent with recognised
local and national standards.
Each service has a process for assessing the quality and completeness of patient records. This is a
part of the health facility's performance improvement activities and is carried out regularly. The clinical
record review is based on a representative sample of the practitioners providing care and of the types
of care provided. The review process is conducted by doctors, nurses and other relevant clinical
professionals, who are authorised to make entries in the patient records. The focus of the review is on
the quality of the records and the clinical information available during the care process. This applies to
records kept on carry cards, as well as patient files.
Standards
The most urgent information needs of those sources influence the organisation's information
management strategies and its ability to implement those strategies. The strategies are appropriate
for the organisation's size, complexity of services, availability of trained personnel and other human
and technical resources. The plan is comprehensive and includes all the departments and services of
the organisation.
There is a system integrating administrative data such as numbers of patient per department,
enrolment data, utilisation, bed occupancy rates and human resources data supported by IT or paper
administration systems. The collection of data is based on the systematically investigated need for
information within the organisation.
4.1.1 Criteria
4.1.1.1. The health facility uses a health information system that facilitates the collection and utilisation of
data.
4.1.1.2. The information system includes data required to measure the objectives set for each programme
provided by the health facility.
4.1.1.3. The requirements for the collection, collation, validation and distribution of data are clearly defined in
the system.
4.1.1.4. The system identifies those permitted access to each category of data and information.
4.1.1.5. The health facility collects data in a timely and efficient manner.
4.1.1.6. Systems are in place for the storage and retrieval of patient information.
The health facility determines how often data are aggregated and analysed. The frequency depends
on the activity or area being measured, the frequency of measurement, and the health facility's
priorities. For example, clinical data may be analysed weekly to meet local regulations, and patient fall
data may be analysed monthly if falls are infrequent. Thus aggregation of data at points in time
enables the health facility to judge a particular process's stability or a particular outcome's predictability
in relation to expectations.
When the health facility detects or suspects an undesirable change from what is expected, it initiates
intense analysis to determine where best to focus improvement. In particular, intense analysis is
initiated when levels, patterns or trends vary significantly or undesirably from:
• what is expected;
• those of other health facilities; or
• recognised standards.
Certain events related to specific processes always result in intense analysis to understand the cause
and prevent recurrence. When appropriate to the health facility's services, these events include:
• confirmed transfusion reactions;
• significant adverse drug reactions;
• significant medication errors;
• significant discrepancies between preoperative and postoperative diagnoses; and
• significant adverse anaesthetic events.
Each health facility establishes which events are significant and the process for their intense analysis.
When undesirable events can be prevented, the health facility works to carry out preventive changes.
The goal of data analysis is to be able to compare a health facility in four ways:
• with itself over time, such as month to month, or one year to the next;
• with other similar health facilities, such as through reference databases;
• with standards, such as those set by accrediting and professional bodies, or those set by laws or
regulations; and
• with desirable practices identified in the literature, such as practice guidelines.
These comparisons help the health facility to understand the source and nature of undesirable change
and help to focus improvement efforts.
Understanding statistical techniques is helpful in data analysis, especially in interpreting variation and
in deciding where improvement is needed. Run charts, control charts, histograms and Pareto charts
are examples of statistical tools that are useful when seeking to understand trends and variations in
health care.
4.2.1 Criteria
4.2.1.1. Data is aggregated, analysed and transformed into useful information.
4.2.1.2. The frequency of data analysis is appropriate to the process under study.
4.2.1.3. The frequency of data analysis meets the requirements of the health facility.
4.2.1.4. Intense analysis of data takes place when there are significant adverse levels, patterns or trends, as
established by the health facility.
4.2.1.5. Statistical tools and techniques are used in the analysis process when suitable.
4.4.2.2. The complete patient record containing notes by medical, nursing and other health professionals
should be readily available to health care providers.
4.4.2.3. There is a standardised format for recording patient assessment and treatment.
4.4.2.4. The signature and designation can be identified for each patient record entry.
4.4.2.5. The date of each patient record entry can be identified.
4.4.2.6. The plan of care for each patient is noted in the patient record.
4.4.2.7. Nursing care plans are updated after each shift.
4.4.2.8. All procedures and diagnostic tests requested are noted in the patient's record.
4.4.2.9. There is evidence of review of the results of procedures and diagnostic tests performed.
4.4.2.10. Re-assessments are documented in the patient's record.
4.4.2.11. Medications prescribed and administered are recorded for each patient.
4.4.2.12. Adverse drug reactions are noted in the patient's record.
4.4.2.13. Medication errors are reported through a process and within a time frame defined by the organisation.
4.4.2.14. Patient and family education provided is noted in the patient's record.
4.4.2.15. Follow-up instructions are recorded in the patient's record.
4.4.2.16. Patient records are reviewed regularly and results analysed as part of the quality improvement
process.
4.4.3. A discharge summary is written for each in-patient, and made available in the
patient's record.
Intent of 4.4.3
The discharge summary is one of the most important documents to ensure continuity of care and
facilitate correct management at subsequent visits. Information provided by the organisation may
include when to resume daily activities, preventive practices relevant to the patient's condition and,
when appropriate, information on coping with disease or disability.
The summary contains at least:
a) the reason for admission
b) the diagnosis of main and significant illnesses
c) the results of investigations that will influence further management
d) all procedures performed
e) the patient's condition at discharge
f) discharge medications and follow-up instructions.
4.4.3 Criteria
4.4.3.1. A discharge summary, which includes items a) to f) in the intent statement, is written by the medical
practitioner at the discharge of each patient.
4.4.3.2. Each record contains a copy of the discharge summary.
organisation develops and implements a policy that guides the retention of patient records and other
data and information. Patient records and other data and information are retained for sufficient periods
to comply with law and regulation and support patient care, the management of the organisation, legal
documentation, research and education. The retention policy is consistent with the confidentially and
security of such information. When the retention period is complete, patient records and other data
and information are destroyed appropriately.
Facilities make more and more use of electronic systems, requiring these standards and criteria to be
assessed appropriately in such instances. These electronic systems vary greatly in their application
and can range from a simple spreadsheet to register all patient admissions/folders, to very
sophisticated systems where the entire patient record is kept electronically.
Often, organisations do not have a single, central location from where records are managed and it is
important to apply the standards and criteria to ALL areas where patient records are being handled,
stored or archived. All these areas (that are under the control/management of the organisation) need
to be visited during the survey, even if located off site (e.g. across the street, on an adjacent plot, or
within reasonable travelling distance). This assessment does not include warehouses of private
companies to whom the archiving of records has been contracted out, as the service
agreement/contract will have to make provision for monitoring compliance with specifications.
4.5.1 Criteria
4.5.1.1. A designated individual is responsible for the storage, maintenance and retrieval of health records.
4.5.1.2. The health facility manager ensures that policies and procedures are implemented to guide the
personnel.
4.5.1.3. Policies and procedures relate to the safeguarding of information in the record against loss, damage,
breach of confidentiality, or use by unauthorised persons.
4.5.1.4. There is a system, which allows for the rapid retrieval and distribution of health records.
4.5.1.5. The filing system allows for incorrectly filed records to be easily identified (e.g. through colour coding
of the records).
4.5.1.6. The health facility has a policy on the retention of patient records and other data and information.
4.5.1.7. The retention process provides the necessary confidentiality and security.
4.5.1.8. Policies and procedures are developed for health record destruction, specifying the criteria for
selection and the method of destruction.
4.5.1.9. There is provision for authorised access to patient records at all times.
4.5.1.10. Storage space for health records is sufficient and secure against unauthorised entry.
5.Risk Management
Effective management includes the planning, education and monitoring of resources needed to safely
and effectively support the clinical services provided in the in-patient, day care and home care settings.
All the personnel are taught how to reduce risks, and how to monitor and report situations that pose
risk. Criteria are used to monitor important systems and identify needed improvements.
Planning should consider the following areas in all settings, when appropriate to the activities of the
organisation.
• Occupational health and safety programmes – the organisation complies with legislation relating
to health and safety and risk management.
• Fire safety – property and occupants are protected from fire and smoke.
• Emergencies – responses to disasters and emergencies are planned and effective.
• Hazardous materials – the handling, storage and use of flammable and other materials are
controlled and hazardous waste is safely disposed of.
• Security – property and occupants are protected from harm and loss.
The provision of health and safety services, emergency planning and other aspects of providing a safe
environment all require personnel and volunteers to have the necessary knowledge and skills for their
implementation.
Standards
Monitoring of all aspects of the programme provides valuable data to make improvements in the
programme and further reduce risks within the organisation.
5.1.1 Criteria
5.1.1.1. There are documented risk management processes for identifying all risks (physical, environmental,
medico-legal, operational, etc) relating to organisational processes and systems, personnel, patients,
visitors and physical facilities.
5.1.1.2. Management and leaders ensure the development and implementation of written policies and
procedures for risk management processes and activities.
5.1.1.3. On-going in-service training of all personnel in these policies, procedures and risk management
principles, including reporting of adverse events, is documented.
5.1.1.4. One or more qualified and/or skilled and/or experienced individuals supervise the implementation of
the risk management system.
5.1.1.5. There is a system for monitoring negative incidents/near misses/ adverse (sentinel) events and it
includes the documentation of interventions and responses to recorded incidents.
5.1.1.6. Risk management systems are reviewed whenever there are changes in organisational systems and
processes, or physical facilities.
5.2.1 Criteria
5.2.1.1. The organisation provides its personnel with occupational health services.
5.2.1.2. Where applicable, legislation regarding occupational health services is implemented.
5.2.1.3. The organisation has access to the services of a knowledgeable and experienced person in the field
of occupational health.
5.2.1.4. Written policies and procedures on all aspects of health and safety guide the personnel in maintaining
a safe work environment.
5.2.1.5. The occupational health service provides information and training on risks specific to the health care
workers.
5.2.1.6. First aid kits/materials for health care workers are available.
5.2.1.7. Post exposure prophylaxis (PEP) is available to the personnel in accordance with organisational
policy.
5.3. Security
5.3.1. As part of risk management, the organisation makes provision for the safety
and security of personnel, volunteers, patients, visitors and buildings.
Intent of 5.3.1
The organisation has a responsibility to ensure that personnel, volunteers, patients and visitors are
safe from attacks or theft by intruders. The organisation identifies areas and groups that are
vulnerable and require added security.
The health facility takes responsibility for protecting patients from physical assault by outsiders, other
patients and personnel. This responsibility is particularly relevant to infants and vulnerable children,
the elderly, and others unable to protect themselves or signal for help. Each health facility identifies its
vulnerable patient groups and establishes a process for protecting the rights of individuals in those
groups. Vulnerable patient groups and the health facility's responsibility may be identified in laws,
charters or regulations. Comatose patients and patients with mental or emotional disabilities are also
included. Protection extends beyond preventing physical assault to other areas of safety. Verbal and
other forms of abuse, negligent care, withholding health facilities, and failing to provide assistance in
the event of a fire or other emergency are all aspects of safety and require vigilance.
The health facility seeks to prevent assault through processes such as investigating individuals in the
facility without identification, monitoring remote or isolated areas of the facility and quickly responding
to those thought to be in danger of assault.
The personnel understands their responsibilities in these processes.
Plans are developed and implemented to provide protection. The loss of organisation property must
be prevented.
5.3.1 Criteria
5.3.1.1. Security systems, including guards, provide for internal security.
5.3.1.2. There is effective control of access to restricted areas in the facility, e.g. laboratory, pharmacy, etc.
5.3.1.3. Security systems, including guards, provide for external security.
5.3.1.4. The health facility has a process for protecting patients and personnel from assault.
5.3.1.5. A mechanism, known to the personnel, is available for summoning the assistance of
security/police/protection service in the case of an emergency.
5.3.1.6. Alarm systems and signals are tested every month.
The organisation develops and implements a policy and plan to eliminate smoking in the organisation's
facilities, or to limit smoking to designated non-patient care areas.
5.4.1 Criteria
5.4.1.1. There are structured systems and processes in place to ensure that all occupants of the
organisation's facilities are safe from fire or smoke.
5.4.1.2. Documented certification is available from the relevant authority to show that the facility complies with
applicable laws and regulations in relation to fire safety (e.g. fire clearance certificate).
5.4.1.3. Fire fighting equipment is regularly inspected and serviced at least annually; the date of the service is
recorded on the apparatus.
5.4.1.4. Flammable materials are clearly labelled and safely stored.
5.4.1.5. Easily recognised and understood signs prohibiting smoking are displayed in areas where flammable
materials and combustible gases are stored.
5.4.1.6. A floor plan, showing the location of fire fighting equipment, electrical distribution board, evacuation
routes and emergency exits, is displayed.
5.4.1.7. Annual staff training in fire prevention and evacuation procedures is documented.
Intent of 5.5.1
Community emergencies, epidemics and disasters (such as damage to patient care areas as a result
of an earthquake, or flu that affects the personnel) may directly involve the organisation.
Organisations should also be prepared for bomb threats, fire, flooding, natural disasters, failure of
water and electrical supplies, hostage taking, explosions and the consequent loss of vital services.
There may be a time when it is necessary to evacuate patients. This can only be done quickly and
effectively if the personnel are trained in evacuation procedures.
To respond effectively, the organisation develops a plan and tests it. The plan provides processes for
alternate care sites, if needed, and alternate sources of medical supplies, communications equipment,
and other materials, such as food and water if an inpatient unit or day care centre exists on the
premises.
5.5.1 Criteria
5.5.1.1. There is a written plan to deal with emergencies (including bomb threats, fire, flooding, natural
disasters, failure of water and electrical supplies).
5.5.1.2. Documented evidence is available to show that the personnel participate in a rehearsal of the plan at
least annually.
Infections can enter the organisation via patients, their families, staff members, volunteers, visitors,
other individuals and vectors. Thus, all areas of the organisation where these individuals or vectors are
found must be included in the programme of infection surveillance, prevention and control.
One or more individuals, acting on a full-time or part-time basis, direct the programme. The
qualifications needed depend on the activities they will carry out; the requirements may be met
through education, training or experience. Co-ordination involves communication with all parts of the
organisation to ensure that the programme is continuous and proactive.
Whatever the mechanism chosen by the organisation to co-ordinate the infection control programme,
medical and nursing personnel are represented and engaged in the activities. The individual,
committee, or other mechanism must also monitor those housekeeping and other support service
practices which may lead to the spread of infection, e.g. cleaning, linen supply, laundry services and
waste disposal.
Hand washing, barrier techniques and disinfecting agents are fundamental to infection prevention and
control. The organisation identifies those situations in which the use of masks and gloves is required
and provides training in their correct use. Soap and disinfectants are located in those areas where
hand washing and disinfecting procedures are required. The personnel are educated in proper hand
washing and disinfecting procedures.
5.6.1 Criteria
5.6.1.1. An individual member of staff is identified to be responsible for infection control in the organisation.
5.6.1.2. All patient, staff and visitor areas of the facility are included in the documented infection control
programme.
5.6.1.3. Written policies and procedures guide the personnel in the implementation of the infection control
programme.
5.6.1.4. The infection control programme is monitored through a document audit process.
5.6.1.5. Regular in-service training is given to all personnel in the field of infection control and is documented.
5.6.1.6. Hand washing and disinfecting facilities, including water, soap, paper towels or hand sanitizers are
available in all relevant areas.
5.6.1.7. Personnel are constantly reminded of the importance of effective hand washing, e.g. posters are
displayed.
5.6.1.8. Protective clothing (gloves, masks, aprons etc.) is available and used correctly.
5.6.1.9. The organisation uses risk, rate and trend information to design or modify processes to reduce
nosocomial infections to the lowest possible levels.
5.6.1.10. The organisation reports information on nosocomial infections and notifiable diseases to appropriate
external public health agencies.
5.6.2. The organisation has a written plan for handling, storing and disposing of
waste.
Intent of 5.6.2
Household waste, hazardous wastes, such as chemicals, hazardous gases and vapours,
pharmaceutical and healthcare waste, are identified by the organisation and are safely controlled
according to a plan. All clinical waste is regarded as hazardous or potentially hazardous. The plan is
included in the organisation's risk management plan.
5.6.2 Criteria
5.6.2.1. There is a waste management system, consistent with current local bylaws and regulations.
5.6.2.2. The system includes safe handling, storing and disposing of different types of waste.
5.6.2.3. Handling, storing and disposing of healthcare waste is included in the plan.
5.6.2.4. There is a colour coding system for the bags to be used for segregating the different types of waste.
CARE OF PATIENTS
A plan for each patient is based on an assessment of needs. That care may be preventive, palliative,
curative or rehabilitative and may include the use of medications, supportive therapies, or a
combination of these approaches. A patient's illness or physical condition may require early attention,
and should be "fast tracked", to prevent a long wait in the queue. Policies describing the recognition of
such patients are available and procedures are in place to expedite early treatment.
It is essential that assessments are well-documented and can be easily retrieved from the patient's
record. As part of assessing patient care needs, diagnostic tests may be required. The health facility
has access to laboratory or radiography services. These facilities are available within an appropriate
time frame.
A health facility should be able to provide some form of emergency care, depending on its mission and
resources, and the needs of the community. Some patients may present at the health facility with
respiratory or cardiac distress, while others may respond adversely to medications administered at the
health facility. Survival depends on, inter alia, the early recognition of cardiopulmonary arrest, early
activation of trained responders, early cardiopulmonary resuscitation and early defibrillation, when
indicated. The level of emergency care and resuscitation to be provided must be clearly defined in
written documents. Those items of equipment deemed to be necessary for resuscitation are listed and
regular equipment checks are carried out. Individuals in patient care areas are responsible for
checking resuscitation equipment every day, or after each use, whichever comes first. Records of
these tests are maintained. Resuscitation equipment is accessible within one minute in all patient care
areas.
Guidelines are available for the assessment and treatment of patients for each programme. Practice
guidelines provide a means of improving quality and assist practitioners and patients in making
healthcare decisions. Guidelines are found in the literature under many names, including practice
parameters, practice guidelines, patient care protocols, standards of practice and health facility
pathways. Regardless of the source, the scientific basis of guidelines should be reviewed and
approved by the health facility leaders and health facility practitioners, before implementation. This
ensures that they meet the criteria established by those leaders and are adapted to the community,
patient needs, and health facility resources. Once implemented, guidelines are reviewed on a regular
basis to ensure their continued relevance.
Every patient is offered the education he or she requires. All personnel within the health facility work
collaboratively to provide education in a co-ordinated manner. Education is focused on the specific
knowledge and skills the patient and his or her family will need to make decisions about care,
participate in care, and continue care at home. Variables like educational literacy, beliefs and
limitations are taken into account. Each health facility decides on the placement and format of
educational assessment, planning and delivery of information in the patient's record. Education in
areas that carry high risk to patients, is routinely provided by the health facility. Standardised materials
and processes are used where possible.
Learning occurs when attention is paid to the methods used to educate patients and their families. The
health facility selects appropriate educational methods and people to provide the education.
Staff collaboration helps to ensure that the information patients and families receive is comprehensive,
consistent, and as effective as possible.
Information provided by the health facility may include when to resume daily activities, preventive
practices relevant to the patient's condition and, when appropriate, information on coping with disease
or disability.
Standards
An assessment is made as to whether the facility has the required furniture and equipment. Facilities
will be required to complete an inventory of their furniture and equipment based on the standard lists
and to report the percentage of total items they have in stock relative to the total recommended.
The physical facilities required include adequate office accommodation for the personnel.
Cleaning equipment is safely stored in a room or cupboard, used expressly for this purpose. Toilet
facilities are adequate for the patients and the personnel.
Lighting and ventilation are adequate.
6.2.1 Criteria
6.2.1.1. Patient and staff accommodation in the outpatient service is adequate for the personnel to provide
patient care.
6.2.1.2. The lay-out of the facility allows for effective flow of patient care.
6.2.1.3. The required furniture and equipment is available in accordance with established lists and is
functioning properly.
6.2.1.4. Stretchers and wheel chairs are available and are functioning properly.
6.2.1.5. Oxygen supplies (oxygen cylinders or air enrichers) meet the patient needs.
6.2.1.6. Where there are no piped oxygen installations, there is a documented procedure for ensuring that
cylinder pressures (i.e. contents) are constantly monitored while patients are receiving oxygen.
6.2.1.7. Oxygen cylinders are stored in accordance with local safety standards.
The screening assessment leads to an understanding of the type of preventive, palliative, curative and
rehabilitative services needed by the patient. This information is used to determine the most
appropriate setting(s) required to meet the patient's most urgent needs. Thus, admission to the health
facility and/or referral to another setting may be required to meet the patient's needs.
The patient's needs may have been determined by a physician or other health facility before they
entered the health facility. If the patient's needs were not determined prior to entry, those needs are
identified through a triage process, screening assessment, or medical history and physical
examination. Diagnostic testing may also be required to:
• determine the patient's needs;
• determine whether the health facility has the appropriate resources to treat the patient; or
• establish whether the patient should be referred or transferred to another setting for care.
6.3.1 Criteria
6.3.1.1. There is a system, which includes patient identification, for initiating screening at the point of first
contact.
6.3.1.2. The screening assessment leads to an understanding of the types of preventive, palliative, curative
and rehabilitative services needed by the patient.
6.3.1.3. There is a system for ensuring that patients are seen within the shortest possible time.
6.3.1.4. Patients who require early attention are identified (e.g. the very frail or ill, or women in an advanced
stage of pregnancy).
6.3.1.5. There is a system for "fast tracking" patients requiring early attention.
6.3.1.6. Waiting times are monitored as part of the organisation's quality management and improvement
programme and kept to the minimum.
6.3.2. All patients cared for by the health facility have their healthcare needs
identified through a comprehensive assessment process.
Intent of 6.3.2
When a patient enters a health facility, the specific information required and the procedures for
obtaining and documenting it, depend on the patient's needs and on the setting in which care is being
provided.
The health facility defines, in writing, the scope and content of assessments to be performed by each
clinical discipline within its scope of practice and applicable laws and regulations.
The health facility determines the time frame for completing assessments. This may vary in the
different settings within the health facility. When an assessment is partially or entirely completed
outside the health facility, the findings are verified on admission to the health facility.
These findings are used throughout the care process to evaluate patient progress and understand the
need for reassessment. It is essential that assessments are well-documented and that they can be
easily retrieved from the patient's record.
6.3.2 Criteria
6.3.2.1. Policies and procedures for assessing patients on arrival and during ongoing care are implemented.
6.3.2.2. Written procedures ensure that assessments are performed within appropriate time frames.
6.3.2.3. Patient assessments are conducted by staff members who have been identified as competent to do
so.
6.3.2.4. Policies and procedures guide the care of high-risk patients and the provision of high-risk services.
6.3.2.5. Current clinical guidelines relevant to the organisation's patients and services are used to standardise
care processes.
6.4.2.11. Records of these checks are kept, with reports on problems experienced, advice given, and any
remedial action taken.
6.5.2. The health facility designs and carries out processes for providing continuity of
patient care services.
6.5.2 Criteria
6.5.2.1. Arrangements are in place to ensure that adequate referral services are available.
6.5.2.2. Referrals outside the facility are to specific individuals and/or agencies in the patient's home
community wherever possible.
6.5.2.3. There are written guidelines for referring emergency patients.
6.5.2.4. Patients and, as appropriate their families, are given follow-up instructions, which are provided in an
understandable form and manner.
6.5.2.5. A copy of the referral letter is available in the patient's record.
Intent of 6.6.1
Every patient is offered access to contraceptive services and education on reproductive health. All
personnel are trained to recognise and meet the specific needs of adolescents and youth. All
personnel in the health facility work collaboratively to provide education in a co-ordinated manner.
Education is focused on the specific knowledge and skills the patient will need to make decisions on
the use of contraceptive methods. Variables like educational literacy, beliefs and limitations are taken
into account. Standardised materials and processes are used where possible. Data is collected (e.g.
logbook), analysed and used to provide relevant information for improving the service, e.g. the number
of contraceptives/condoms used per month.
6.6.1 Criteria
6.6.1.1. Guidelines for providing contraceptive services and are available and are followed.
6.6.1.2. The personnel show evidence of education for and competence in providing a contraceptive service.
6.6.1.3. A range of most frequently prescribed contraceptive methods is provided, including injectable
hormonal contraceptives, oral hormonal contraceptives, barrier methods and emergency
contraceptives.
6.6.1.4. The personnel who are authorised to insert intra-uterine contraceptive devices show evidence of
current training and competence in the procedure.
6.6.1.5. A record of the chosen method for each patient is available.
6.6.1.6. Guidelines regarding the advice to be given to patients on sterilisation are available and are followed.
6.6.1.7. Guidelines regarding the advice to be given to patients on termination of pregnancy are available and
are followed (TOP).
6.6.1.8. Guidelines for administering post-coital contraceptives are available and are followed.
6.6.1.9. Condoms are freely available from strategically placed condom dispensers.
6.6.1.10. Guidelines for PEP in the case of sexual violence are available and are followed.
These findings will include the diagnosis of pregnancy and the measurements during follow up, which
may include weight, blood pressure, oedema, protein in urine, fever and activity of the foetus. It is
essential that assessments are documented well and can be easily retrieved from the patient's record.
The frequency of follow up visits should be clearly indicated.
Country-specific clinical guidelines and protocols are available to ensure up to date treatment of
complications during pregnancies and side effects of treatment with regard to the foetus. National
guidelines must be used if available.
6.6.2 Criteria
6.6.2.1. Guidelines for routine tests, observations and examinations to be conducted on pregnant women are
available and are followed.
6.6.2.2. The personnel show evidence of education and competence in the provision of antenatal care.
6.6.2.3. Policies cover the screening for syphilis and treatment according to the result.
6.6.2.4. All tests, observations and examinations are recorded.
6.6.2.5. Guidelines for referring patients with complicated pregnancies to specialist services are available and
are followed.
6.6.2.6. Guidelines for educating pregnant women in preparation for breast feeding are available and are
followed.
6.6.2.7. Guidelines for caring for HIV-positive obstetric patients are available and are followed.
6.6.3. Where midwifery services are provided, there are adequate resources to
ensure safe and effective care.
6.6.3 Criteria
6.6.3.1. Guidelines for the provision of midwifery services are available and are followed.
6.6.3.2. Guidelines (such as Emergency Obstetric Care) are used to reduce the number of maternal deaths in
the labour ward.
6.6.3.3. A registered/professional nurse with midwife training/experience is present at every birth.
6.6.3.4. At least one person who is competent in the management of maternal and neonatal emergencies is
available for consultation at all times.
6.6.3.5. Guidelines for managing labour are available and are followed.
6.6.3.6. Observations during labour are recorded on a partograph.
6.6.3.7. Guidelines for the active management of the third stage of labour, including post-partum bleeding are
available and are followed.
6.6.3.8. There is a system for disposing safely of placentas.
6.6.3.9. Information on cases and the outcome of deliveries are recorded in a register/log book.
6.6.3.10. There is an established process for conducting vacuum extractions or for referring patients who need
vacuum extractions.
6.6.3.11. There is an established process for conducting Caesarean sections or for referring patients who need
Caesarean sections.
6.6.6.5. Policies address the issues of breastfeeding (transmission risk) and its alternatives and the provision
of breast milk substitutes in accordance with guidelines.
6.6.6.6. Policies address the follow-up testing of infants born to mothers with HIV infection in accordance with
guidelines.
6.7.2. Services are provided to promote the health and growth of children.
6.7.2 Criteria
6.7.2.1. Guidelines for measuring the growth and development of children and referring them appropriately
where growth or development are delayed, and the Integrated Management of Childhood Illnesses
(IMCI) manual are available and are followed.
6.7.2.2. The child health chart is completed after each visit.
6.7.2.3. Guidelines for hearing tests for children are available and are followed.
6.7.2.4. A programme promoting breastfeeding is followed.
6.7.2.5. Children with nutritional deficiency disorders are identified, managed or appropriately referred.
6.7.2.6. There is an oral rehydration service, which includes counselling.
6.7.2.7. The health facility is adolescent- and youth-friendly and meets the specific healthcare needs of these
groups in accordance with national guidelines.
6.8.3 Criteria
6.8.3.1. There is a system for sputum microscopy.
6.8.3.2. The outcomes of sputum testing are monitored.
6.8.3.3. Tuberculosis (TB) treatment accords with current guidelines.
6.8.3.4. There is an uninterrupted medicine supply for TB treatment.
6.8.3.5. The facility has a TB infection control management plan that is implemented.
6.8.3.6. The principles of directly observed treatment are adhered to.
6.8.3.7. Policies and procedures relate to community support of the directly observed TB treatment and are
implemented.
6.8.3.8. Supporters (community or family) of the directly observed TB treatment are provided with appropriate
training.
6.8.3.9. Patients with positive tuberculosis test results are counselled and provided with HIV testing.
6.11.1 Criteria
6.11.1.1. Guidelines for assessing and treating patients with chronic non-communicable diseases (e.g.
hypertension, diabetes, cardio-vascular, etc) are available and are followed.
6.11.1.2. Appropriate equipment is available for conducting the assessments.
6.11.1.3. Patients are provided with the necessary aids, as appropriate to their needs.
6.11.1.4. Equipment and materials for the provision of wound care are provided.
6.11.1.5. Wound care procedures/guidelines/standard operating procedures (SOP) are available and are
followed.
6.11.2. The healthcare facility provides care and treatment for mental disorders,
within its capabilities.
6.11.2 Criteria
6.11.2.1. Guidelines, including mental health legislation, for assessing and treating patients attending the
mental health service are available and are followed.
6.11.2.2. There is access to mental health expertise, when required (a psychiatrist or psychologist, as
appropriate).
6.11.3. The health facility provides preventive and promotive programmes for oral
health, and curative services as appropriate to meet the needs of the community.
6.11.3 Criteria
6.11.3.1. Guidelines for oral health assessment, education and treatment are available and are followed.
6.11.3.2. Where there is an oral hygienist, he/she is competent to conduct oral examinations and to provide
oral hygiene, in accordance with current documented guidelines.
6.11.3.3. Medicines are available for dental use.
6.11.3.4. Materials are available for local anaesthesia.
6.11.3.5. The dental service works with the infection control personnel in the health facility to ensure that
infection control policies and procedures are implemented.
7.In-patient Care
Certain activities are basic to patient care, including planning and delivering care to each patient,
monitoring the patient to understand the results of the care, modifying care when necessary and
completing the follow-up.
Many medical, nursing, pharmaceutical, rehabilitation and other types of healthcare providers may
carry out these activities. Each provider has a clear role in patient care. Credentialing, registration,
law and regulation, an individual's particular skills, knowledge and experience, and organisational
policies or job descriptions determine that role. The patient, the family or trained caregivers may carry
out some of this care.
A plan for each patient is based on an assessment of needs. That care may be preventive, palliative,
curative or rehabilitative and may include the use of anaesthesia, surgery, medication, supportive
therapies, or a combination of these approaches. A plan of care is not sufficient to achieve optimal
outcomes unless the delivery of the services is co-ordinated, integrated and monitored.
From entry to discharge or transfer, several departments, services and different health care providers
may be involved in providing care. Throughout all phases of care, patient needs are matched with
appropriate resources within and, when necessary, outside the organisation. This is accomplished by
using established criteria or policies that determine the appropriateness of transfers within the
organisation.
Processes for continuity and co-ordination of care among physicians, nurses and other healthcare
providers must be implemented in and between all services.
Leaders of various settings and services work together to design and implement the required
processes to ensure co-ordination of care.
Standards
The patient, family and others are included in the decision process when appropriate.
The patient's record contains a history of all care provided by the multidisciplinary team, and is made
available to all relevant caregivers who are authorised to have access to its content.
7.1.2 Criteria
7.1.2.1. There is a regular schedule of ward rounds with medical personnel.
7.1.2.2. Information exchanged includes a summary of the care provided.
7.1.2.3. Information exchanged includes patient response to treatment.
There are adequate toilet and bathing facilities for the number of patients in the ward
There is adequate lighting and ventilation. Emergency call systems are available at bedsides and in bathrooms
and toilets. The emergency call system is connected to the emergency power system.
Where there is no piped oxygen and vacuum supply, there are mobile oxygen cylinders and vacuum pumps. All
the necessary fittings for oxygen and suction are in place and working satisfactorily. Each bed is serviced by at
least one electrical socket outlet. Each ward is provided with a socket outlet that is connected to the emergency
power supply.
7.2.1 Criteria
7.2.1.1. Patient and staff accommodation in the service is adequate to meet patient care needs.
7.2.1.2. Oxygen supplies (oxygen cylinders or air enrichers) meet the patient care needs.
7.2.1.3. Suction supplies meet the patient care needs.
7.2.1.4. Where there are no piped oxygen installations, there is a documented procedure for ensuring that
cylinder pressures (i.e. contents) are constantly monitored while patients are receiving oxygen.
7.2.1.5. There is a dedicated area in the ward kitchen for preparing infant feeds, where applicable.
7.2.1.6. There is a separate room for the personnel to hand over between shifts, write reports, hold meetings,
etc.
7.2.1.7. Separate sanitary facilities are provided for the personnel.
7.2.1.8. Separate ablution facilities are available in the ward for the patients.
7.2.1.9. There is a separate scullery/sluice room for patients' eliminations, waste and laundry.
7.2.2. Adequate resources are available for providing safe care to patients in the
ward.
7.2.2 Criteria
7.2.2.1. Bed devices (frames/cot-sides, cradles, bed blocks, etc) are available and functional.
7.2.2.2. Bedside facilities (bedside table/locker, chair/bench) are available.
7.2.2.3. Each patient has access to a nurse call system at all times.
7.2.2.4. Each bed space is provided with adequate lighting.
7.2.2.5. Ward screens are available to ensure privacy.
7.2.2.6. Resuscitation equipment is available in accordance with the policies of the organisation.
7.2.2.7. Equipment and materials are provided for the provision of patients' personal hygiene are provided.
7.2.2.8. Mattresses, bed linen, towels and pyjamas for patients are available and in good condition.
7.2.2.9. Equipment and materials for facilitating patients' mobility are available and in good condition.
7.2.2.10. Equipment and materials for monitoring patients' vital signs are provided.
7.2.2.11. Equipment and materials for wound care and treating fractures are provided.
7.3.1. Policies and procedures/SOPs guide the care of patients and the provision of
services.
Intent of 7.3.1
Policies and procedures are important to help personnel understand the facility's patients and
services, and to respond in a thorough, competent and uniform manner. The clinical and managerial
leaders take responsibility for identifying the needs of the patients and the services to be provided and
use a collaborative process to develop policies and procedures and to train the personnel in their
implementation.
It is particularly important that the policies or procedures indicate:
- how planning will occur;
- the documentation required for the care team to work effectively;
- special consent considerations;
- monitoring requirements;
- special qualifications or skills of the personnel involved in the care process; and
- the availability and use of resuscitation equipment, including equipment for children.
Clinical guidelines are frequently helpful and may be incorporated in the process. Monitoring provides
the information needed to ensure that the policies and procedures are adequately implemented and
followed for all relevant patients and services.
Policies and procedures should focus on high risk patients and procedures, e.g.
- the care of emergency patients;
- the handling, use and administration of blood and blood products;
- the management of contaminated blood supplies (expired, opened or damaged containers);
- the care of patients with communicable diseases;
- the care of immuno-suppressed patients;
- the use of restraint and the care of patients in restraint;
- the care of frail, dependent elderly patients;
- the care of young, dependent children;
- the security of newborn babies.
7.3.1 Criteria
7.3.1.1. Policies and procedures for nurses are available and are followed as indicated in the statement of
intent above.
7.3.1.2. Nurses use performance checklists/protocols/guidelines for complex skills, e.g. intravenous infusions,
catheterisation, nasogastric intubation.
7.3.1.3. The personnel are trained and use the policies and procedures to guide care.
7.3.2. Clinical practice guidelines are used to guide patient care and reduce
unwanted variation.
Intent of 7.3.2
Practice guidelines provide a means to improve quality and assist practitioners and patients in making
clinical decisions. Guidelines are found in the literature under many names, including practice
parameters, practice guidelines, patient care protocols, standards of practice. Regardless of the
source, the scientific basis of guidelines should be reviewed and approved by the organisation's
leaders and clinical practitioners before implementation. This ensures that the guidelines meet the
criteria established by the leaders and are adapted to the community, patient needs and the resources
of the organisation. Once implemented, guidelines are reviewed on a regular basis to ensure their
continued relevance.
7.3.2 Criteria
7.3.2.1. Clinical practice guidelines, relevant to the patients and services of the organisation, are used to
guide patient care processes.
7.3.2.2. Guidelines are used in clinical monitoring as part of a structured clinical audit.
7.3.2.3. Guidelines are reviewed and adapted on a regular basis after implementation.
When guidelines and other related tools are available and relevant to the patient population and
mission of the organisation, there is a process for evaluating and adapting them to the needs and
resources of the organisation, and for training the personnel to use them.
Patients and their families or decision-makers receive adequate information to participate in care
decisions. Patients and families are informed as to what tests, procedures and treatments require
consent and how they can give consent, e.g. verbally, by signing a consent form, or through some
other mechanism. Patients and families understand who may, in addition to the patient, give consent.
Designated staff members are trained to inform patients and to obtain and document patient
consent. These staff members clearly explain any proposed treatments or procedures to the patient
and, when appropriate, the family. Informed consent includes:
• an explanation of the risks and benefits of the planned procedure;
• identification of potential complications; and
• consideration of the surgical and non-surgical options available to treat the patient.
In addition, when blood or blood products may be needed, information on the risks and alternatives is
discussed.
The organisation lists all those procedures that require informed written consent. Leaders document
the processes for obtaining informed consent.
The consent process always concludes with the patient signing the consent form, or the
documentation of the patient's verbal consent in the patient's record by the individual who provided the
information for consent. Documentation includes the statement that the patient acknowledged full
understanding of the information. The patient's surgeon or other qualified individual provides the
necessary information and the name of this person appears on the consent form.
7.4.1 Criteria
7.4.1.1. The initial assessment results in the identification of the patient's medical, nursing or other healthcare
needs.
7.4.1.2. There is documented evidence that patients' vital signs are monitored, registered and interpreted
according to a regular daily schedule.
7.4.1.3. Procedures for the elimination of patients' secretions are implemented.
7.4.1.4. Wound care procedures/guidelines/standard operating procedures (SOP) are available and are
followed.
7.4.1.5. Wound dressings are inspected daily and where indicated the wound is inspected.
7.4.1.6. When indicated, the dressing is changed.
7.4.1.7. Measures are in place to prevent immobility and prevent the complications of immobility.
7.4.1.8. There is evidence that the patient is encouraged to become active and to use aid appliances, where
necessary, to stimulate the rehabilitation process.
7.4.1.9. There is evidence that the patient, when confined to bed or immobile, receives assistance with lifting,
moving, positioning, turning in bed and transferring from and back to bed.
7.4.1.10. There is evidence that pressure relieving techniques (care of skin, turning in bed on schedule,
observing and preventing potential bedsores) are implemented and documented.
7.4.1.11. Patients receive professional physiotherapy care and assistance with rehabilitation if required.
Dying patients have unique needs for respectful, compassionate care. Concern for the patient's
comfort and dignity guides all aspects of care during the final stages of life. To accomplish this, all the
personnel are made aware of the unique needs of patients at the end of life. These needs include
treatment of primary and secondary symptoms, pain management, responding to the concerns of the
patient and family and involving them in care decisions.
7.4.2 Criteria
7.4.2.1. The organisation implements processes for addressing the patient's needs for appropriate
assessment and management of pain.
7.4.2.2. The organisation educates health professionals in assessing and managing pain.
7.4.2.3. Policies and procedures regarding the care of dying and deceased patients are implemented.
7.5.1.1. Medical assessments are carried out and documented before patients go to surgery.
7.5.1.2. The results of surgical patients' diagnostic tests are recorded before surgery.
7.5.1.3. Surgical patients' preoperative diagnoses are recorded before surgery.
7.5.1.4. The anaesthetic assessment identifies any drug sensitivities.
7.5.1.5. An intra-operative report and a post-operative diagnosis are documented.
7.5.1.6. The names of the surgeon and other personnel as required by law, are documented.
7.5.1.7. The patient's clinical status is monitored during the immediate post-surgery period.
Staff collaboration helps to ensure that the information patients and families receive is comprehensive,
consistent, and as effective as possible.
Education is focused on the specific knowledge and skills that the patient and his or her family will
need to make decisions about care, participate in care, and continue care at home.
Variables like educational literacy, beliefs and limitations are taken into account.
Each organisation decides the placement and format for educational assessment, planning and
delivery of information in the patient's record.
Education is provided to support care decisions of patients and families. In addition, when a patient or
family directly participates in providing care, for example changing dressings, feeding and
administering medication, they need to be educated.
It is somethimes important that patients and families are made aware of any financial implications
associated with care choices, such as choosing to remain an inpatient rather than being an outpatient.
Education in areas that carry high risk to patients is routinely provided by the organisation, for instance
instruction in the safe and effective use of medications and medical equipment.
Community organisations that support health promotion and disease prevention education are
identified and, when possible, ongoing relationships are established.
7.6.1 Criteria
7.6.1.1. Patients and families learn about participation in the care process.
7.6.1.2. Patients and families learn about any financial implications of care decisions.
7.6.1.3. Patients are educated about relevant high health risks, e.g. the safe use of medication and medical
equipment, or medicine and food interactions.
7.6.1.4. The patient and family are taught in a language and format that they can understand.
7.6.1.5. Information given to the patient and family is noted in the patient's record.
7.6.1.6. There is evidence in the patient health record that he or she gave informed consent
SPECIALISED SERVICES
Anaesthesia, sedation and surgical interventions are common and complex processes in a health care
organisation. They require complete and comprehensive patient assessment, integrated care
planning, continued patient monitoring and criteria-determined transfer for continuing care,
rehabilitation and eventual discharge.
Anaesthesia and sedation are commonly viewed as a continuum from minimal sedation to full
anaesthesia. As patient responses may move along that continuum, the use of anaesthesia and
sedation is organised in an integrated manner. This chapter includes anaesthesia and moderate and
deep sedation, during which the protective reflexes needed by the patient for ventilator functions are at
risk.
The anaesthesia and surgery standards are applicable wherever anaesthesia and/or moderate or deep
sedation are used and surgical and other invasive procedures requiring consent are performed. Such
settings include clinic/healthcare centre operating theatres, day surgery or day clinic/healthcare centre
units, dental and other outpatient clinics, emergency services and others. While major surgery is
generally not performed in clinics/health centres, a number of minor procedures might be undertaken.
The organisation ensures that an adequate number of suitably qualified and experienced personnel
are available at all times to provide a safe operating theatre and anaesthetic service.
Standards
The qualifications of those persons who administer anaesthesia in the clinic/healthcare centre are
documented in accordance with current professional society standards.
There may not be a formally constituted Theatre Users' Committee, but the function must be
performed at some level. For example, in the private sector there are clinical forums where medical
practitioners meet with management. These forums include representatives of the theatre nursing
staff.
Privileges assigned to Individuals may not be documented, but the organisation places restrictions on
who may administer anaesthetics. In the private sector, privileging is implied by the fact that
anaesthetists are allowed to provide services in an organisation only once their credentials have been
checked.
8.1.1 Criteria
8.1.1.1. A senior professional, who is suitably qualified and/or experienced, is in charge of the theatre and
recovery area.
8.1.1.2. Operating theatre rosters ensure that registered nurses with suitable qualifications and/or experience
are present during all shifts, for theatre duties, anaesthetic assistance, and for recovery room duties.
8.1.1.3. Anaesthesia is administered only by qualified practitioners, who are privileged by the organisation to
do so.
8.1.1.4. Anaesthesia is commenced and terminated only in the presence of a staff member whose sole duty it
is to assist the anaesthetist, until such time as the latter indicates that assistance is no longer
required.
8.1.1.5. There is at least one suitably trained and/or experienced anaesthetic nurse per operating theatre.
8.1.1.6. Nurses, trained in recovery room care, are available until the patient has fully recovered.
8.1.1.7. The anaesthetist is responsible for supervising the recovery period and authorising the patient's
discharge.
Theatre personnel are provided with office facilities or a day station, a restroom, washrooms, toilets,
changing facilities and a separate space for their personal clothing and theatre clothing.
There are facilities for scrubbing-up procedures in each theatre, with hot and cold running water and
elbow-operated taps. There is an anaesthetist's chair, an operating table with Trendelenburg position
control, at least one lateral padded straight arm support, and an infusion pole. Equipment for patients
awaiting surgery includes blood pressure monitoring equipment, vacuum points with ancillary fittings
and oxygen points with flowmeters and all ancillary fittings. Space and facilities are available for
setting up surgical trays and for autoclaving instruments.
8.2.1 Criteria
8.2.1.1. The design of the operating theatre complex provides space for the reception, anaesthesia, surgery,
recovery and observation of patients.
8.2.1.2. Access to the theatre suites is controlled.
8.2.1.3. There is direct access to the operating theatres from the receiving, scrubbing-up and recovery areas.
8.2.1.4. The accommodation for patients awaiting surgery is suitably equipped.
8.2.1.5. There is safe and adequate storage space for pharmaceutical and surgical supplies.
8.2.1.6. There is access to sterilisation and disinfection facilities.
8.2.1.7. There is a system for controlling the environmental temperature and humidity, that ensures safe limits
for anaesthetised patients (temperature between 22 degrees Celcius and 25 degrees Celcius and
relative humidity between 40% and 70%).
8.2.1.8. There is either an uninterrupted power supply (UPS) or a battery backup system for the theatre lamp,
which is regularly tested, with such tests being fully documented.
8.2.1.9. There is a functional operating theatre table, which is regularly tested, with such tests being fully
documented.
8.2.1.10. The theatre has a refrigerator for medications, the temperature of which is measured and recorded
daily.
8.2.2. The anaesthetic equipment, supplies and medications used comply with the
recommendations of professional anaesthetic organisations, or alternate authoritative
sources.
8.2.2 Criteria
8.2.2.1. The provision and use of anaesthetic mixture components and other peri-operative medication
complies with the guidelines of a professional society or similar reputable professional body.
8.2.2.2. The provision and use of breathing circuits complies with the guidelines of a professional society or
similar reputable professional body.
8.2.2.3. The provision and use of ancillary equipment complies with the guidelines of a professional society or
similar reputable professional body.
8.2.2.4. The provision and use of monitoring equipment complies with the guidelines of a professional society
or similar reputable professional body.
8.2.2.5. An anaesthesia trolley is available for the exclusive use of the anaesthetist in each theatre.
8.2.2.6. Expiry dates of medications are checked regularly, with documented records of such checks.
8.2.2.7. A tracheotomy tray is available.
8.2.2.8. Theatre personnel ensure that all equipment is included in the organisation's equipment replacement
and maintenance programme.
8.2.3. Emergency and protective equipment and supplies are provided in the
operating theatre.
8.2.3 Criteria
8.2.4. Recovery room facilities and equipment are available to provide safe and
effective care.
Intent of 8.2.4
The number of beds/trolley spaces in the recovery room provides sufficient space for at least one
patient from each operating theatre that it services, and is sufficient for peak loads. The provision, use
and maintenance of recovery room equipment comply with the guidelines for practice of the
professional society.
8.2.4 Criteria
8.2.4.1. The recovery area forms part of the operating theatre complex.
8.2.4.2. There is an adequate number of recovery beds for the patients from the operating theatre.
8.2.4.3. There is adequate lighting.
8.2.4.4. The provision, use and maintenance of recovery room equipment comply with the professional
society's guidelines.
8.2.5. The sterilising and disinfecting unit is designed to allow for effective sterilising
and disinfecting of equipment and supplies.
Intent of 8.2.5
Even in a small one-room unit, the separation of activity sites and the flow of work can be achieved by
careful planning. There should be a dedicated area for cleaning equipment and instruments.
There are many methods of sterilising equipment. Whatever methods are used, the personnel need to
ensure that the equipment used is effective. There must, therefore, be established systems for
ensuring that sterility is obtained through the sterilisation processes.
The number of autoclaves required will depend upon the size of the clinic/healthcare centre and the
services provided, how much is processed on site and how much is acquired pre-packed and sterilised
and whether the needs of both the operating theatre suite and other departments/services are catered
for.
8.2.5 Criteria
8.2.5.1. The design of the sterilising and disinfecting unit, and the layout of equipment, ensures flow of work
from the soiled to the clean side of the unit.
8.2.5.2. There is a washing and decontamination area, with stainless steel sinks and running water, and a
sanitary sewage system.
8.2.5.3. There is a pre-packing area with storage facilities for clean materials.
8.2.5.4. There is a storage area for sterile packs with racks that allow for an adequate circulation of air.
8.2.5.5. Adequate light and ventilation are available.
8.2.5.6. There are one or more autoclaves or their equivalents that are capable of sterilising porous loads
(gowns, drapes and dressings), as well as wrapped and unwrapped instruments.
8.2.5.7. Where ethylene oxide is used as a sterilising agent, the installation complies with relevant safety
standards and legislation.
8.2.5.8. Autoclave sterility is tested daily and the test results are recorded.
8.2.5.9. The sterility of each pack is shown on indicator tapes that are suited to the processes used.
Biohazards that need to be monitored and notified include radiation, laser and electrical hazards.
Policies and procedures are available to ensure that informed consent is documented, the patient is
correctly identified, and the nature of and the site for surgery are correctly documented. Processes
during the surgery, such as the use of instruments and counting procedures, are documented to
ensure co-ordination and safety.
The implementation of policies will be assessed on site. For example, the assessor will require the
person in charge to describe their performance step by step, while showing where and when/how to
get the required equipment. At the same time, expiry dates, functioning of equipment and sterilisation
issues will be checked.
8.3.1 Criteria
8.3.1.1. There are written policies and procedures to guide the activities of the theatre and the anaesthetic
service.
8.3.1.2. Policies and procedures are developed relating to the preparation of patients for surgery.
8.3.1.3. Policies and procedures are developed relating to intra-operative recording.
8.3.1.4. Policies and procedures are developed relating to the anaesthetic service.
8.3.1.5. There are guidelines relating to the administration of major regional anaesthesia.
8.3.1.6. There are guidelines relating to the use of conscious sedation, where applicable.
8.3.1.7. Policies and procedures comply with current guidelines of the professional society.
The anaesthetic planning process includes educating the patient and his or her family or decision-
maker regarding the risks, potential complications, and options related to the planned anaesthesia and
postoperative analgesia. This discussion occurs as part of the process of obtaining consent for
anaesthesia. The anaesthesiologist or the qualified individual who will administer the anaesthetic
provides this education.
8.4.1 Criteria
8.4.1.1. An anaesthetic assessment of the patient is performed before the anaesthesia is administered.
8.4.1.2. The medical assessment of surgical patients is documented before the start of the anaesthesia.
The anaesthetist has access to the patient care notes, and is familiarised with the findings of the
medical examination. It is important that each health professional has access to the records of other
care providers, in accordance with organisational policy.
8.4.2 Criteria
8.4.2.1. The patient's physiological status is continuously monitored and recorded during anaesthesia and
surgery.
8.4.2.2. The anaesthesia used is entered in the patient's anaesthetic record.
Monitoring during anaesthesia provides the basis for monitoring during the post-anaesthetic recovery
period. The ongoing, systematic collection and analysis of data on the patient's status in recovery may
support decisions about moving the patient to other settings and less intensive services. Only a
suitably qualified and experienced registered nurse or designated member of the medical staff may
carry out monitoring in the recovery area. Recording of monitoring data provides the documentation to
The anaesthetist or other qualified individual decides whether the patient can be discharged from the
recovery area to another level of care or from the organisation (as in the case of ambulatory
anaesthesia). Standardised criteria developed by medical personnel are used to make discharge
decisions. The decision to discharge the patient from the recovery area is entered into the patient's
record. The time of arrival in, and discharge from, the recovery area are recorded. The signatures of
those who handed over and those who received the patient are recorded.
8.4.3 Criteria
8.4.3.1. During the post-anaesthetic recovery period, patients receive monitoring appropriate to their
condition.
8.4.3.2. Monitoring findings are entered in the patient's record.
8.4.3.3. Established criteria are used to make decisions regarding the patient's discharge from the recovery
room.
8.4.3.4. The decision to discharge the patient is recorded.
8.4.3.5. Recovery area arrival and discharge times are recorded.
8.4.3.6. The signatures of those handing over and those receiving the patient are recorded.
9.Laboratory Services
The facility may have its own laboratory service, or it may have an arrangement with an outside
laboratory service. In either case, the service must meet applicable standards, laws and regulations.
The selection of an outside source to receive laboratory specimens for analysis is based on an
acceptable record and compliance with laws and regulations.
Laboratory services must be available at those times needed by the organisation, including emergency
and after-hour services.
Standards
The laboratory services are organised and provided in a manner that meets applicable local and
national standards, laws and regulations.
Laboratory services, including those required for emergencies, may be provided within the
organisation, by agreement with another organisation, or both. Laboratory services are available after
normal hours for emergencies.
Outside sources are convenient for the patients. The organisation selects outside sources based on
the recommendations of the director or other individual responsible for laboratory services. Outside
sources of laboratory services meet applicable laws and regulations and have acceptable records of
accurate, timely services. Patients are informed when an outside source of laboratory services is
owned by the referring physician.
Laboratory results are validated to ensure that they are those of the correct patient and physician.
Validations include the name of the validating officer.
Results are reported within a time frame based on patient needs, services offered, and the needs of
the clinical personnel. Emergency tests and after-hours and weekend testing needs are included.
Appropriate specimen containers are available in the organisation, with instructions for their correct
use.
9.1.1 Criteria
9.1.1.1. Adequate, convenient and regular laboratory services are available to meet the organisation's needs.
9.1.1.2. The laboratory services are organised and provided in a manner that meets applicable local and
national standards, laws and regulations.
9.1.1.3. Emergency laboratory services are available, including after-hours services.
9.1.1.4. The organisation has established the expected report time for results.
9.1.1.5. Laboratory results are reported within a suitable time frame to meet patient needs.
9.1.1.6. Laboratory results are validated and include unique patient identity, date of testing/reporting, name
and location of the requesting physician.
9.1.1.7. The validating officer is identified and recorded.
9.1.1.8. A list of referral laboratories is available for tests not performed on site.
9.1.1.9. There is a documented, implemented procedure for packaging specimens and transporting them to
the referral laboratories.
9.1.1.10. A register is kept of the referred specimens and the results.
The laboratory service is under the direction of an individual who is qualified by virtue of documented
training, expertise and experience, in accordance with applicable laws and regulations. This individual
assumes professional responsibility for the laboratory facility and for the services provided. When this
individual provides clinical consultations or medical opinions, he or she is a physician, preferably a
pathologist. Speciality and subspecialty laboratory services are under the direction of appropriately
qualified individuals. The responsibilities of the laboratory director include:
− developing service-related policies and procedures and ensuring that they are implemented;
− managing relevant human resource functions, e.g. job descriptions, personnel evaluation, staff
training;
− developing, co-ordinating, and monitoring the required quality control and improvement systems.
9.1.2 Criteria
9.1.2.1. The laboratory is under the direction of a qualified individual.
9.1.2.2. The responsibilities of this person include maintaining quality control programmes.
9.1.2.3. The responsibilities of this person include administrative supervision.
9.1.2.4. The responsibilities of this person include monitoring and reviewing all the laboratory services.
9.1.3. Individuals with adequate training, skills, orientation and experience administer
tests and interpret the results.
Intent of 9.1.3
The organisation identifies the laboratory personnel who may perform testing and who may direct or
supervise testing. Supervisory and technical personnel have appropriate and adequate training,
experience and skills, and are oriented to their work. Technical personnel are given work assignments
consistent with their training and experience. In addition, there are enough staff members to perform
tests promptly and to provide the necessary laboratory staffing during all hours of operation and for
emergencies.
The organisation is able to identify and contact experts in specialised diagnostic areas, such as
parasitology or virology, when needed.
9.1.3 Criteria
9.1.3.1. Those individuals who may perform testing and those who may direct or supervise testing are
identified.
9.1.3.2. There are enough staff members to meet service needs.
9.1.3.3. On-going in-service training is provided to all staff members.
9.1.3.4. Records of the training provided are kept for each staff member.
The general state of the laboratory will be checked. The walls, floor and ceiling should be in a good
condition. As few items/instruments as possible should be placed on the floor.
9.2.1 Criteria
9.2.1.1. The laboratory is a separate designated area within, or in close proximity to, the health facility.
9.2.1.2. The size of the laboratory is appropriate to the services provided.
9.2.1.3. The ceiling and walls are clean and painted in a bright colour.
9.2.1.4. The floor has a smooth and continuous surface.
9.2.1.5. The ceiling is not leaking and does not show signs of moisture.
9.2.2. Laboratory fixtures and fittings are adequate to provide a safe and effective
laboratory service.
Intent of 9.2.2
The laboratory benches and equipment should be of an easily cleaned material (NO WOOD).
Assessors will check that:
• benches are not damaged;
• benches, walls and equipment are clean (no dust, blood or other material on walls);
• waste bins are not over-filled;
• the area around the water point is clean and organised.
9.2.2 Criteria
9.2.2.1. There are sufficient laboratory benches for the projected activities.
9.2.2.2. Laboratory benches are strong enough for the projected activities (e.g. large instruments).
9.2.2.3. There is either an UPS or a battery backup system for selected items of equipment, which are tested
regularly and the results are fully documented.
9.2.2.4. Each laboratory compartment has adequate ventilation, with room temperature below 25 degrees
Celsius, and a temperature record is kept.
The refrigerator temperature, especially the specimen fridge temperature, must be maintained
between 2ºC and 8ºC and records of the daily temperature checks must be kept.
9.2.3 Criteria
9.2.3.1. Sufficient equipment is available to provide the required laboratory services for the projected
activities.
9.2.3.2. All equipment is in good working order, operated appropriately, and functioning well.
9.2.3.3. Records are maintained to indicate that all equipment is regularly inspected, maintained and
calibrated.
There should be at least two log-books: only one Patient log-book and, depending on the size of the
laboratory, one or more Laboratory log-books for various disciplines.
Laboratory results should ideally not be directly linked to names, either in the Patient or the Laboratory
log-books.
Patient log-books should contain name, date of visit, date of birth, gender, which tests were requested,
Ideally, monthly overviews of the number of tests performed are generated; test results of all quality
control specimens performed should be well documented. Most important, it is essential that raw data
is administered, documented, filed and remains in the laboratory.
These procedures are observed for specimens sent to outside laboratory sources for testing, and for
specimens sent to on-site laboratories.
There are records of results given telephonically, at what time and to whom.
9.4.1 Criteria
9.4.1.1. Policies and procedures (SOPs) for handling specimens are implemented.
9.4.1.2. Request forms are available and contain relevant information.
9.4.1.3. Specimen labels include unique patient identification and adequate supporting information.
9.4.1.4. Specimens are registered (handwritten or digital) legibly and in an organised manner.
9.4.1.5. Results are registered in a log-book.
9.4.1.6. Laboratory results are stored in lockable cupboard.
9.4.1.7. Policies and procedures (SOPs) regarding reporting and reviewing results are implemented.
9.4.2. Established norms and ranges are used to interpret and report clinical
laboratory results.
Intent of 9.4.2
The laboratory establishes reference intervals or "normal" ranges for each test performed. The range
is included in the clinical record, either as part of the report or by including a current listing of such
values, approved by the laboratory director. Ranges are furnished, when an outside source performs
the test. The reference ranges are appropriate to the organisation's patient population and are
reviewed and updated when methods change.
9.4.2 Criteria
9.4.2.1. The laboratory has established reference ranges for relevant tests.
9.4.2.2. The range is included in the clinical record at the time test results are reported.
Sound quality control systems are essential to providing excellent pathology and clinical laboratory
services. Quality control procedures could include:
a) validation of the test methods used for accuracy, precision and reportable range;
b) daily surveillance of results by qualified laboratory staff;
Proficiency testing determines how well an individual laboratory's results compare with other
laboratories that use the same methodologies. Such testing can identify performance problems not
recognised by internal mechanisms. Thus, the laboratory participates in an approved proficiency
testing programme when one is available. Alternatively, when approved programmes are not
available, the laboratory exchanges samples with a laboratory in another organisation for peer
comparison testing purposes. The laboratory maintains a cumulative record of participation in a
proficiency testing process. Proficiency testing, or an alternative, is carried out for all speciality
laboratory programmes, when available.
9.5.1 Criteria
9.5.1.1. There is a documented quality control system.
9.5.1.2. The laboratory participates in an external quality control programme.
9.5.1.3. There is a current register of quality control results and of the corrective and preventive actions taken.
These needs may be met by a service within the organisation, or may be outsourced. In either case,
the diagnostic imaging service must comply with all applicable local and national standards, laws and
regulations.
The organisational leaders ensure that where a diagnostic imaging service is provided by the facility,
there are radiation safety programmes in place, and that individuals with adequate training, skills,
orientation and experience are available to undertake diagnostic imaging procedures and interpret the
results.
The diagnostic imaging service allows for immediate decision-making by practitioners, through the
provision of emergency services and the provision of emergency reports, as necessary.
Standards
Outside sources are convenient for the patients and reports are received in a timely manner, which
supports continuity of care. These sources are selected by the organisation on the recommendation of
the director or another individual responsible for radiology and diagnostic imaging services. Outside
sources of diagnostic imaging meet applicable laws and regulations and have acceptable records of
accurate, timely service. Patients are informed when the referring physician owns the outside source
of diagnostic imaging.
10.1.1 Criteria
10.1.1.1. An adequate, convenient and regular diagnostic imaging service is available.
10.1.1.2. An emergency diagnostic imaging services is available after normal hours.
10.1.1.3. The selection of an outside source is based on an acceptable record and compliance with applicable
laws and regulations.
10.1.2. The diagnostic imaging service meets applicable local and national
standards, laws and regulations.
Intent of 10.1.2
The organisation ensures that the personnel are knowledgeable about the relevant legal requirements
relating to diagnostic imaging. This is ensured by having available copies of the most recent radiation
safety report and the local rules relating to the current Ionising Radiation regulations, together with
other applicable documents that provide guidance relating to legality.
The organisation satisfies the statutory requirements of the Ionising Radiation regulations, according to
the most recent radiation safety report.
There are organisational arrangements for obtaining advice on radiation protection and how to deal
with a suspected case of overexposure.
10.1.2 Criteria
10.1.2.1. Written policies and procedures address compliance with applicable standards, laws and regulations.
10.1.2.2. A copy of the local rules relating to the current Ionising Radiation regulations is available and the
requirements are met.
10.1.2.3. A copy of the most recent radiation safety report is held.
10.1.2.4. The organisation satisfies the statutory requirements of the Ionising Radiation regulations.
10.1.2.5. A radiation protection supervisor is identified and available to assist a radiation protection adviser in
complying with the Ionising Radiation regulations.
The organisation has identified the quantities of film, reagents and supplies necessary to provide a
radiology and diagnostic imaging service to its patients. There is an effective process for ordering or
securing essential film, reagents and other supplies. All supplies are stored and dispensed in
accordance with defined procedures. The periodic evaluation of reagents ensures accuracy and
precise results. Written guidelines ensure the complete and accurate labelling of film, reagents and
solutions.
10.2.2 Criteria
10.2.2.1. Essential quantities of film, reagents and supplies are available.
10.2.2.2. All reagents and solutions are completely and accurately labelled.
10.2.2.3. Film and reagents are periodically evaluated for accuracy and results.
The organisation is able to identify and contact experts in specialised diagnostic areas such as
radiation physics, radiation oncology, or nuclear medicine, when the need for such services arises.
The organisation maintains a roster of such experts.
10.3.1 Criteria
10.3.1.1. A qualified individual manages the diagnostic imaging service.
10.3.1.2. Those individuals who may perform X-ray procedures and those who may interpret and report the
results are identified.
10.3.1.3. There is a mechanism that ensures that procedures are performed only by radiographers,
radiologists, or specially trained doctors and other persons who are authorised to do so by a radiation
protection advisor.
10.3.1.4. X-rays are done only upon a signed request from a qualified medical practitioner.
10.3.1.5. X-rays are interpreted and reported on by appropriately trained and experienced personnel.
10.3.1.6. Experts in specialised diagnostic areas are contacted, when needed.
10.3.1.7. A roster of experts for specialised diagnostic areas is maintained.
10.3.1.8. Quality control procedures are implemented.
10.3.2. Reporting and recording policies and procedures within the diagnostic
imaging service ensure safety and legality.
Intent of 10.3.2
X-ray request forms and the ensuing reports must identify the correct patient and the correct site of X-
ray. The organisation defines the time period for reporting diagnostic imaging test results. Results are
reported within a time frame based on patients' needs, the services offered and the needs of the
clinical personnel. Mechanisms are in place to ensure that X-ray results are reported on immediately
in an emergency.
The X-ray films are the property of the patient, and may be taken away by the patient. Where this is
done, the patient must be asked to bring the films for future visits. Where the organisation stores films
they are kept according to country-specific regulations.
10.3.2 Criteria
10.3.2.1. Imaging request forms contain the patient's name, examination requested, relevant previous
examinations and clinical information to explain the request.
10.3.2.2. Diagnostic imaging results are reported on by a qualified person within a time frame that meets
clinical needs.
10.3.2.3. X-ray reports by a qualified person contain a clear conclusion (including recommendations for future
treatment if appropriate).
10.3.2.4. A copy of the report is filed in the patient's record.
10.3.2.5. Films are available at each visit of the patient.
10.3.2.6. Policy defines the length and method of storage of X-ray films.
10.3.3. Where ultrasound services are provided, individuals with adequate training,
skills and experience perform the procedures and interpret the results.
Intent of 10.3.3
The organisation identifies those staff members who may perform ultrasound procedures and those
who may interpret and report the findings. These staff members have appropriate and adequate
training, experience and skills, and are oriented to their work.
10.3.3 Criteria
10.3.3.1. A qualified individual manages the ultrasound service.
10.3.3.2. Those individuals who may perform ultrasound procedures and those who may interpret and report
the results are identified.
10.3.3.3. Ultrasound procedures are performed only by individuals with specific training.
10.3.3.4. Ultrasound images are interpreted and reported on by appropriately trained and experienced staff
members.
10.3.3.5. Experts in specialised diagnostic areas are contacted, when needed.
10.3.3.6. A roster of experts for specialised diagnostic areas is maintained.
10.3.3.7. Quality control procedures are implemented.
11.Medication Management
Standards
Intent of 11.1.1
As an important resource in patient care, the use of medication is managed effectively and efficiently
throughout the organisation.
Applicable laws and regulations are incorporated into the organisational structure and the operations of
the medication management system used in the organisation.
Where the organisation dispenses medication it must be an approved licensed site with the relevant
personnel having approved licences issued for that site in accordance with country-specific legislation.
A registered pharmacist directly supervises the activities of the pharmacy or pharmaceutical service.
11.1.1 Criteria
11.1.1.1. A designated individual, who is suitably qualified, has clearly defined responsibilities and
accountability for all aspects of the pharmaceutical service.
11.1.1.2. Individuals who dispense medications act in accordance with legislation affecting pharmacy practice
and current pharmaceutical, medical and nursing guidelines.
11.1.1.3. The scope of and limitations to the responsibilities and activities of the personnel who manage
medications are clearly defined.
11.1.1.4. The name of the responsible pharmacist is clearly displayed.
11.1.1.5. The pharmaceutical service is co-ordinated with other related services within the health facility.
Deep freeze, refrigeration, cold room and cool area facilities are provided for safe storage of certain
medications. There is a mechanism for ensuring that the correct temperature is maintained throughout
the life of the medications. Deep freezers and refrigerators are defrosted when necessary. Doors,
hinges and seals are all functional.
11.2.1 Criteria
11.2.1.1. The design and layout of the pharmacy must permit a logical, safe flow of work, adequate storage
space, effective communication supervision and ensure effective cleaning and maintenance.
11.2.1.2. Secure facilities for the storage of medications include, but are not limited to, lockable storage
facilities, ceiling cages, burglar guards and alarm systems with keypads.
11.2.1.3. The storage area is easily accessible from the dispensing room.
11.2.1.4. Medication storage areas are protected from heat and light and are effectively ventilated.
11.2.1.5. A dedicated refrigerator is available for those medications requiring storage at low temperatures.
11.2.1.6. A monitoring log is kept of the temperature within the refrigerator and/or cold-chain monitors; any
remedial action taken is recorded.
11.2.1.7. The work bench for preparing medicines for dispensing should be clean, tidy and well organised.
11.2.1.8. The area where medicines are dispensed to the patients is easily accessible, adequately furnished
and allows for reasonable privacy when advice is given.
On occasion, medications not readily available to the organisation are needed. There are also
occasions where medications are needed at times when pharmacies are closed. Each organisation
needs to plan for these situations and to educate the personnel regarding the procedures to follow
should they occur. When patient emergencies occur, quick access to appropriate emergency
medications is critical. Each organisation plans the location of emergency medications, and the
medications to be supplied in these locations. To ensure access to emergency medications when
needed, the organisation establishes a procedure or process to prevent theft or loss of the
medications, and to ensure that medications are replaced when used, or when damaged or out of
date. Each organisation also needs to determine its role in providing medications to patients at
discharge. Those who prescribe or order medication know what medications, if any, are available and
how to obtain them.
11.4.1 Criteria
11.4.1.1. There is a list of the medications stocked in the organisation or readily available from outside sources.
11.4.1.2. Priority essential drugs are in stock.
11.4.1.3. There is a process for obtaining required medications that are not stocked, or normally available to
the organisation.
11.4.1.4. There is a process for healthcare workers to obtain medicines within the facility when the pharmacy is
closed.
11.4.1.5. There is a list of medications available in the emergency cupboard, where relevant.
Medications stored and dispensed from areas outside the pharmacy, for example patient care units,
comply with the same safety measures.
There is a registry, log or other mechanism for monitoring and accounting for controlled substances.
11.5.1 Criteria
11.5.1.1. Medications are stored in a locked storage device or cabinet, which is accessible only to authorised
personnel.
11.5.1.2. There is a system for ensuring that maximum and minimum stock levels are maintained.
11.5.1.3. Medications are legibly marked and securely labelled.
11.5.1.4. Medications controlled by law or organisational policy are stored in a cabinet of substantial
construction, for which only authorised personnel have the keys.
11.5.1.5. Medications controlled by law or organisational policy are accurately accounted for in a specific
register.
11.5.1.6. Hazardous and flammable materials are stored, in accordance with relevant regulations.
11.5.1.7. All pharmaceuticals, vaccines or medical consumables are regularly checked for expiry dates and
checks are recorded.
11.5.1.8. An inventory management system, manual (stock cards) or automated, is in place and functioning
appropriately, e.g. to monitor and control stock losses.
11.5.1.9. Separate designated storage areas are provided for materials under quarantine are provided, e.g.
expired stock, compounded products.
The organisation dispenses medications in the most ready-to-administer form possible, to minimise
opportunities for error during distribution and administration. The central pharmacy and other
medication distribution points throughout the organisation use the same system. The system supports
accurate dispensing of medications in a timely manner.
11.7.1 Criteria
11.7.1.1. Pharmacy personnel act in accordance with legislation and current pharmaceutical, medical and
nursing guidelines.
11.7.1.2. Medications are prepared and dispensed in a safe and clean environment.
11.7.1.3. There is a uniform medication dispensing and distribution system in the organisation.
11.7.1.4. The system supports accurate and timely dispensing.
11.7.1.5. Medications are securely and legibly labelled with relevant information as required by organisational
policy.
11.7.1.6. A register is maintained of all medicines dispensed.
11.7.1.7. The person prescribing and dispensing the medicine has access to patient information that would
contra-indicate particular medicines.
11.7.1.8. The person dispensing the medicine informs the patient of available generic equivalents.
11.7.1.9. There is a mechanism for facilitating communication between the doctor and the pharmacy regarding
drug reactions.
11.7.1.10. Prescriptions are securely stored in accordance with legislation or organisational policy.
ANCILLARY SERVICES
Laws, regulations and inspections by national governmental and local authorities determine in large
part, how a facility is designed, used and maintained. All organisations, regardless of their size and
resources, must comply with these requirements, as part of their responsibilities to their patients,
families, staff and visitors. Organisations begin by complying with laws and regulations. Over time,
they become more knowledgeable about the details of the physical facility they occupy. They begin to
proactively gather data and carry out strategies to reduce risks and enhance the patient care
environment.
Buildings, grounds, plant and machinery are provided and maintained, and do not pose hazards to the
occupants. Utility systems (electrical, water, oxygen, ventilation, vacuum and other utility systems) are
maintained to minimise the risks of operating failures.
Ensuring that buildings, grounds, plant and machinery are provided and maintained requires that the
personnel be knowledgeable and competent.
Standards
Buildings, grounds, plant and machinery are provided and maintained, and do not pose hazards to the
occupants. The construction of the building in terms of walls, ceilings, floors, door and window must
be sound. The general appearance will be examined for neatness, condition of paint-work, signs of
leakage, mould spots, etc.
Utility systems (electrical, water, oxygen, ventilation, mosquito screening and other utility systems) are
maintained to minimise the risks of operating failures. Ensuring that buildings, grounds, plant and
machinery are provided and maintained requires that the personnel be knowledgeable and competent.
12.1.1 Criteria
12.1.1.1. Laws, regulations and other requirements applicable to the organisation's facilities are available in
writing to the personnel.
12.1.1.2. The building is appropriate as a healthcare facility in terms of size and lay-out.
12.1.1.3. Mosquito net screening is available at the outside windows and doors throughout the facility, where
applicable.
12.1.1.4. All rooms are adequately ventilated.
12.1.1.5. Air-conditioning is installed in theatres and sterilising departments and is tested and maintained.
12.1.1.6. Temperature and ventilation control mechanisms are installed and maintained in the pharmacy,
laboratory, kitchens, laundries and other relevant areas.
12.1.1.7. Toilet/washroom facilities are clean and in working order.
12.1.1.8. There is a separate area for the personnel, with adequate secure storage facilities for outdoor
clothing, handbags and personal possessions.
12.1.1.9. Sufficient office/administrative space is available for the personnel.
Management ensures that enough competent personnel are available to manage routine and
emergency functions and meet the needs of a safe and effective health service. Personnel may be in
the employ of the organisation or be contracted out. Where there are contracted personnel, there
must be clear contracts outlining their responsibilities. The roles of the personnel need to be clearly
defined, and management needs to ensure that they maintain their competence.
12.2.1 Criteria
12.2.1.1. A designated, competent individual is responsible for supervising the maintenance of buildings, plant
and installations.
12.2.1.2. Where these services are outsourced, the organisation's personnel have access at all times to a list of
these private contractors with their contact numbers.
12.2.1.3. Written agreements ensure 24-hour technical back-up services.
12.2.1.4. Written policies and procedures guide the organisation's personnel in the implementation of all
service-related requirements.
12.2.1.5. There is a dedicated work area for maintenance activities.
12.2.1.6. Basic maintenance equipment and tools are available.
12.2.1.7. Basic technical spare parts are available.
12.2.3. Electrical installations are regularly inspected, tested, maintained and, when
appropriate, improved.
Intent of 12.2.3
The effective and efficient operation of all key systems in the organisation is essential for patient,
family, volunteer and visitor safety and for meeting patient care needs.
The organisation needs to protect patients and personnel in emergencies, such as system failure,
interruption or contamination.
An uninterrupted source of electricity is essential to meet patient care needs, both routine and urgent,
24 hours a day. Regular and alternate sources can be used.
Critical points to be lighted by emergency power are identified and listed. These include:
• operating theatres and recovery rooms;
• lights and sockets in the delivery rooms;
• strategic lights and sockets in ward corridors;
• the neonatal nursery; and
• casualty and trauma areas.
12.2.4. Water supplies are regularly inspected, tested, maintained and, when
appropriate, improved.
Intent of 12.2.4
An uninterrupted source of clean water is essential to meet patient care needs, both routine and
urgent, 24 hours a day. Drinkable water needs to be available in all essential areas as medical
departments, wards, OPD and ablution facilities. Storage areas such as a well, storage tanks or other
backup systems must be safe from contamination.
Regular and alternate sources can be used.
Water quality can change suddenly due to many causes, some of which can be outside the
organisation, such as a break in the supply line to the organisation, or contamination of the city's water
source. The frequency of water quality monitoring is based, in part, on previous experience with water
quality problems. The monitoring can be carried out by individuals designated by the organisation,
such as personnel from the clinical laboratory, or by public health or water control authorities outside
the organisation. Records of all checks are available.
Monitoring data is collected and documented for the medical utility management programme and is
used for planning and improvement purposes.
12.2.4 Criteria
12.2.4.1. Regular and/or emergency water supplies, including drinkable water, are available 24 hours a day,
seven days a week in all essential areas.
12.2.4.2. Water filters are available to remove mud and dust particles.
12.2.4.3. Should the water supply be contaminated or interrupted, the areas and services at risk have been
identified and provision has been made for an alternative water supply.
12.2.4.4. There is documented evidence that relevant personnel are regularly trained to ensure that all
operations to secure safe water are properly performed.
12.2.4.5. All drinkable water supplies are tested on a regular basis and the results are documented.
12.2.5. Medical gas systems are regularly inspected, maintained and, when
appropriate, improved.
Intent of 12.2.5
The organisation plans its oxygen supplies according to the needs of the patients served.
Policies and procedures relating to the storage, testing and safety of gas supplies are available and
are implemented.
Gas cylinders are stored in outside facilities, chained in the upright position, and have "no smoking"
and "no oil" signs.
Emergency oxygen supplies ensure that:
• where there is no piped oxygen supply, there is at least one mobile oxygen supply per ward, and
more depending on the number of beds/cots in the ward;
• all the necessary fittings for oxygen are suitable for the ages of the children admitted, and are
working satisfactorily.
12.2.5 Criteria
12.2.5.1. Medical gas (oxygen, nitrous oxide and medical air) supplies are available according to the
operational requirements of the facility.
12.2.5.2. Medical gas supply systems comply with safety standards.
12.2.5.3. Where there is piped gas, the enclosure, gas bank, pressure regulators, related control/alarm
systems and all outlet points are clean and in good operating condition.
12.2.5.4. Where there is piped gas, the main oxygen supply system is fitted with an alarm, which operates
automatically in the event of low pressure in the gas supplies and is regularly tested.
12.2.5.5. Where there is piped gas, medical gas alarm systems are regularly tested, and these tests are
documented.
12.2.5.6. Backup supplies of medical gas are available and strategically positioned to ensure timely
deployment in emergencies.
12.2.6. Medical vacuum systems are regularly inspected, maintained and, when
appropriate, improved.
Intent of 12.2.6
The organisation plans its vacuum supplies, according to the needs of the patients served.
Policies and procedures relating to the testing and safety of vacuum systems are available and
implemented.
Vacuum systems are regularly tested in accordance with the specifications of the suppliers.
• all the necessary fittings for suction are suitable for the ages of the children admitted, and are
working satisfactorily.
12.2.6 Criteria
12.2.6.1. Where there is a piped vacuum system, it is externally ventilated and able to provide sufficient suction
to all piped vacuum points in the hospital.
12.2.6.2. Piped vacuum systems are regularly tested, and these tests are documented.
12.2.6.3. Backup vacuum/suction units are available and strategically positioned to ensure timely deployment
in emergencies.
12.2.7. The sewerage system is regularly inspected, tested, maintained and, when
appropriate, improved.
Intent of 12.2.7
An appropriate sewerage system must be available and maintained. This will include disposal of
waste water, surface water and sewage. The infrastructure, including drainage points, pipes, pumps
and mains, needs to be protected to prevent spillage and contamination of the environment. (A1.2.6)
12.2.7 Criteria
12.2.7.1. There is an appropriate and effective sewerage system.
12.2.7.2. Septic tank systems are properly managed and functional.
12.2.7.3. All drains are appropriately covered.
Intent of 12.4.1
Healthcare organisations are responsible for ensuring that appropriate ICT equipment is available and
ready for use at all times. There is an accountable, systematic approach to ensuring that cost-
effective, safe and appropriate ICT equipment is available to meet the demands of quality patient care.
Managers take responsibility for ensuring that ICT equipment is available, appropriately maintained,
calibrated and that the personnel are competent to use it.
12.4.1 Criteria
12.4.1.1. Policies and procedures guide the management of ICT equipment.
12.4.1.2. A designated individual supervises the management of ICT equipment in the organisation.
12.4.1.3. The supply of ICT equipment is adequate to meet the needs of the services.
12.4.1.4. There is an inventory of all ICT equipment.
12.4.1.5. All desktop and server computers are attached to an uninterrupted power supply (UPS) with surge
protection.
12.4.1.6. There is a data back-up system.
12.4.1.7. Records are kept of the checking and maintenance of ICT equipment.
12.4.1.8. Where technical ICT support is not available at facility level, an arrangement is in place to obtain such
support from outside.
12.4.1.9. There is documented evidence that relevant personnel are regularly trained to use/operate ICT
equipment.
12.4.1.10. There is a documented procedure known to the personnel for reporting defects in ICT equipment
during and after normal working hours.
12.4.1.11. Computers are equipped with officially licensed software only.
12.4.1.12. Operating system patches/updates are installed as they become available.
12.4.1.13. Each computer is equipped with an up-to-date virus scanner.
12.4.1.14. Basic technical spare parts are available.
13.Support Services
In organisations without an in-patient unit, food may be prepared for day care or crèche facilities. In
this case, the same criteria for safe and hygienic food preparation apply.
The managers/supervisors of the services work with other organisational leaders and managers to
improve the quality of service delivery throughout the organisation, and to ensure that services comply
with criteria relating to management, leadership, human resource development, infection control,
environmental safety and quality improvement.
Standards
13.1.2. There are enough suitably qualified and competent personnel to provide a
safe and effective service.
Intent of 13.1.2
Orientation and induction programmes ensure the competence of personnel before they begin to carry
out their functions.
The personnel act in accordance with job descriptions, and are evaluated in accordance with their
assigned responsibilities. The in-service training needs of the personnel in the service are continuously
assessed and appropriate training is provided.
13.1.2 Criteria
13.1.2.1. Personnel employed by the organisation are managed in terms of the employer's policies and
procedures relating to job descriptions, orientation and induction, in-service training and staff
performance appraisals.
13.1.2.2. The manager has established an orientation and induction programme for service personnel.
13.1.2.3. Contracted personnel are managed as determined in the written service agreement.
13.1.2.4. The organisation ensures that contracted personnel are oriented to relevant organisational policies
and procedures.
13.1.2.5. The organisation ensures that contracted personnel participate in relevant organisational in-service
training programmes (e.g. infection control, health and safety).
13.1.3. The food service department is designed to allow for the effective storage,
preparation and serving of food.
Intent of 13.1.3
The service manager needs to work closely with organisation's managers to ensure that facilities and
equipment are adequate. Management is kept informed of inadequate facilities, additional equipment
requirements and the current state of facilities and equipment.
13.1.3 Criteria
13.1.3.1. Where a kitchen is provided within the facility, it is designed to allow for the effective storage,
preparation and serving of food.
13.1.3.2. There is a section of the kitchen dedicated to the preparation of infant feeds.
13.1.3.3. There are separate hand-washing facilities in the food preparation area, with soap and paper towels.
13.1.3.4. There is a mechanism for preventing unauthorised individuals from entering food preparation areas.
13.1.3.5. The temperature, ventilation and humidity levels are adequate to provide for satisfactory working
conditions and cleanliness.
13.1.3.6. Windows in the preparation area have fly screens or another effective method of fly control is
available.
13.1.3.7. There is adequate lighting.
13.1.3.8. There is a fire extinguisher and a fire blanket in the kitchen.
13.1.6. Food products and meals are hygienically stored, prepared and served.
Intent of 13.1.6
Foods are stored and prepared in accordance with written protocols. High-risk foods which may be
contaminated and which may contaminate other foods are kept separately. This includes such foods
as meat, poultry and fish.
13.1.6 Criteria
13.1.6.1. Foods, which are of a potentially high risk, unprepared food and prepared items, are kept separately.
13.1.6.2. Separate cutting boards are kept for raw and cooked food.
13.1.6.3. Food is kept for a minimal amount of time after cooking and before serving.
13.1.6.4. Food waste is put in covered containers and removed without delay from places where food is
prepared.
13.1.6.5. There is a mechanism for ensuring that food handlers report if they or their family suffer from
diarrhoea or vomiting, throat infections, skin rashes, boils or other skin lesions, or eye or ear
infections.
13.1.6.6. Food handlers wear protective clothing.
13.1.7. Food is stored under conditions that ensure security, hygiene and freshness.
Intent of 13.1.7
Foods are stored under conditions that ensure security, hygiene and freshness. .
13.1.7 Criteria
13.1.7.1. Foods are stored at acceptable temperatures.
13.1.7.2. Foods are stored separately from non-foods.
13.1.7.3. Different types of food are kept separately.
13.1.7.4. Foods are stored off the ground on racks or shelving of an impenetrable material.
13.1.7.5. Fridges and freezers can be opened from the inside through a safety release mechanism.
13.1.7.6. Stock is rotated using the First In First Out principle.
13.2.2. There are enough suitably qualified and competent personnel to provide a
safe and effective service.
Intent of 13.2.2
Orientation and induction programmes ensure the competence of personnel before they begin to carry
out their functions.
The personnel act in accordance with job descriptions and are evaluated in accordance with their
assigned responsibilities. The in-service training needs of personnel in the service are continuously
assessed and appropriate is training provided.
13.2.2 Criteria
13.2.2.1. Personnel employed by the organisation are managed in terms of the employer's policies and
procedures relating to job descriptions, orientation and induction, in-service training and staff
performance appraisals.
13.2.2.2. Contracted personnel are managed as determined in the written service agreement.
13.2.2.3. The organisation ensures that contracted personnel are oriented to relevant organisational policies
and procedures.
13.2.2.4. The organisation ensures that contracted personnel participate in relevant organisational in-service
training programmes (e.g. infection control, health and safety).
13.2.3. Where the laundry is within the facility, it is designed to allow for safe and
effective processing of laundry.
Intent of 13.2.3
Departmental managers need to liaise with organisational managers to ensure that facilities and
equipment are adequate. The organisation's managers are kept informed of inadequate facilities,
additional equipment requirements, and the current state of facilities and equipment.
13.2.3 Criteria
13.2.3.1. The space in the laundry is adequate to deal with the calculated or estimated dry weight of articles to
be processed and the type of washing equipment.
13.2.3.2. The laundry provides a clear flow of laundry from the soiled to the clean side with no crossover of
these lines.
13.2.3.3. The size and number of washing machines are adequate to meet the number of loads per hour,
considering peak loads.
13.2.3.4. Ironers/laundry presses are adequate to ensure the processing of laundry items without undue
delays.
13.2.3.5. Linen is securely stored.
13.3.2. There are enough suitably trained personnel to provide a safe and effective
service.
Intent of 13.3.2
Orientation and induction programmes ensure the competence of personnel before they begin to carry
out their functions.
The personnel act in accordance with job descriptions, and are evaluated in accordance with their
assigned responsibilities. The in-service training needs of personnel in the service are continuously
assessed and appropriate training provided.
13.3.2 Criteria
13.3.2.1. Personnel employed by the organisation are managed in terms of the employer's policies and
procedures relating to job descriptions, orientation and induction, in-service training and staff
performance appraisals.
13.3.2.2. Contracted personnel are managed as determined in the written service agreement.
13.3.2.3. The organisation ensures that contracted personnel are oriented to relevant organisational policies
and procedures.
13.3.2.4. The organisation ensures that contracted personnel participate in relevant organisational in-service
training programmes (e.g. infection control, health and safety).
13.3.3. Facilities and equipment are adequate to provide a safe and effective
cleaning service.
Intent of 13.3.3
Departmental managers need to liaise with the organisation's managers to ensure that facilities and
equipment are adequate.
13.3.3 Criteria
13.3.3.1. Adequate and secure storage areas are available for equipment and chemicals.
13.3.3.2. Chemicals for cleaning are safely stored out of the reach of patients, children and visitors.
13.3.3.3. There is adequate storage place for brooms and mops.
13.3.3.4. Mops and brooms are cleaned and dried before being stored.
13.3.3.5. Cleaning cupboards are adequately ventilated.
13.3.4. Safe waste disposal takes place according to the infection control
programme.
Intent of 13.3.4
The personnel play an important role in the removal of clinical waste from departments. Protocols
need to be developed to guide the personnel in ensuring the in ensuring their own safety, the safety of
others and the safety of the environment when implementing the waste removal systems.
13.3.4 Criteria
13.3.4.1. Waste is segregated in accordance with policies, procedures and municipal by-laws.
13.3.4.2. The colour of bag and type of container appropriate to the type of waste generated are available.
13.3.4.3. Waste is protected from theft, vandalism or scavenging by animals.
13.3.4.4. Waste is collected at appropriate times so that hazards are not caused.