INTERNATIONAL FOR HEALTHCARE STANDARDS

Third Edition

PRINCIPLES

A FRAMEWORK OF REQUIREMENTS FOR STANDARDS

Published by The International Society for Quality in Health Care December 2007 Clarendon Terrace, 212 Clarendon Street, East Melbourne, Victoria 3002, Australia

ISQuas International Principles for Healthcare Standards Third Edition

A FRAMEWORK OF REQUIREMENTS FOR STANDARDS

INTRODUCTION
The process of ISQua standards assessment and international accreditation is a way for external evaluation and standards setting organisations to assure themselves that their standards meet international best practice requirements and to demonstrate this to their clients, funders and other stakeholders. It is now ten years since ISQuas first edition of the international principles for healthcare standards were developed as a guide for standards development and revision. The 2nd edition of the Principles was implemented in August 2004 and has been used by ISQua to accredit over 30 sets of standards covering acute, primary and community services and specialist service areas. Review Process The ISQua Accreditation Council has now reviewed and revised the 2nd edition Principles to ensure: they are based on current evidence, research and sound practice they reflect the current patient safety emphasis of the WHO World Alliance for Patient Safety initiative they are user friendly, understandable, valid, relevant, can be interpreted consistently and facilitate quality improvement and duplication within the Principles is minimised. The review process involved an initial request for comments and suggestions for improvement to organisations that had used or were using the Principles and to ISQua standards assessors. Using this feedback, a working group produced a first draft revision for consideration by the Accreditation Council. A second draft was prepared and circulated to users for comment. It was also posted on the ISQua website and was pilot tested through a self-assessment process by two organisations. The feedback from these processes was used to develop the third draft which was approved with minor changes by the Accreditation Council. 3rd edition Principles The 3rd edition contains six Principles compared with the five Principles in the 2nd edition. The dimensions of quality are no longer grouped within one Principle as in the 2nd edition but are now addressed in four of the Principles. The increased emphasis on safety is reflected by a Principle devoted to that dimension. The revised Principles are: Quality Improvement: Standards are designed to encourage healthcare organisations to improve quality and performance within their own organisations and the wider healthcare system Patient/Service User Focus: Standards are designed with a focus on patients/service users and reflect the patient/service user continuum of care or service

Copyright 2000 - 2007, ISQua The International Society for Quality in Health Care Inc. All rights reserved.
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ISQuas International Principles for Healthcare Standards Third Edition

Organisational Planning and Performance: Standards assess the capacity and efficiency of healthcare organisations Safety: Standards include measures to protect and improve the safety of patients/service users, staff and visitors to the organisation Standards Development: Standards are planned, formulated and evaluated through a defined and rigorous process Standards Measurement: Standards enable consistent and transparent rating and measurement of achievement. Changes to 3rd edition from 2nd edition New requirements for standards include: the definition of organisations values, ethics and strategic objectives evaluation and analysis of performance data and its use for improvement staff planning training of staff on equipment clinical risk assessments infection control patient safety issues patient/service user records clear standards framework and clear standards wording. Other changes include: provision of more guidance to assist interpretation and application of the Principles change of numbering to delete sub-criteria amalgamation of some criteria more logical grouping resulting in criteria relating to different dimensions of quality from previous Principle 3 being incorporated in Principles 1, 2, 3 and 4. The attached table identifies the extent to which criteria from the 2nd edition Principles have been incorporated into the 3rd edition.

ISQuas International Principles for Healthcare Standards Third Edition

ISQua Standards Assessment Process

On application to ISQua, organisations will be provided with an assessment tool and guidance documents. The assessment process includes a standards preview, self-assessment and independent standards assessment by an ISQua standards assessment team. The guidance information is not part of the assessment process. It is intended to provide information to assist in applying the Principles to a particular environment or country without reducing the intent of the Principles and criteria. The criteria and Principles will continue to be rated on a three point scale of Met, Partially Met and Not Met and assessors will provide comments on the standards, recommendations and other identified opportunities for improvement. Standards may be ISQua Accredited for up to four years with a requirement to submit an action plan and two progress reports within that period. Implementation Following Accreditation Council and ISQua Board approval, the Principles will be introduced in January 2008 and be applicable to organisations having standards assessed after 30 June 2008. Those organisations having standards assessed before 30 June 2008 may elect to be assessed against either the 2nd or 3rd edition of the Principles. Criteria Principle 1 Revised Principles QUALITY IMPROVEMENT Guidance

Standards are designed to encourage healthcare organisations to improve quality and performance within their own organisations and the wider healthcare system. The standards require healthcare organisations to define, as appropriate to their size and scope, their: mission or purpose values ethics or code of behaviour and strategic objectives. The standards define responsibilities for quality and performance improvement at different levels of the organisation. Responsibilities may be defined for governance, management, clinicians, other staff and, where applicable, volunteers.

1.1

1.2

ISQuas International Principles for Healthcare Standards Third Edition

Criteria 1.3

Revised Principles The standards define the responsibilities of a healthcare organisation for: governance and organisational management.

Guidance a) Governance responsibilities may relate to determining the organisations direction, setting objectives and developing policy to guide the organisation in achieving its mission, and monitoring the achievement of those objectives and the implementation of policy. b) Organisational management responsibilities may relate to setting targets or goals for the future through planning and budgeting for the organisations range of services, establishing processes for achieving those targets, allocating resources to accomplish those plans and ensuring that plans are achieved by organizing, staffing, controlling and problem-solving.

1.4

The standards require healthcare organisations to inform the public of: the services they provide and the quality and performance of the services. The standards require that policies, procedures or processes and plans for all key functions in the organisation are documented authorised kept current and implemented. The standards require an approach to quality improvement that: is systematic is continuous is organisation-wide covers all aspects of performance supports innovation incorporates monitoring, including of all high risk processes and procedures, and evaluation. Authorisation may be demonstrated by the signature of a person with authority to approve policies and plans, or the recorded decision of a governing body.

1.5

1.6

ISQuas International Principles for Healthcare Standards Third Edition

Criteria 1.7

Revised Principles Guidance The standards require that key care Requirements could include: and service processes and outcomes a) the use of these methods to be measured through the use of: measure functions such as human performance indicators resources, infection control, risk patient/service user satisfaction management and patient/service surveys/assessments and user care and services; other performance measures. b) encouragement of the use of indicators expressed as ratios with defined numerators and denominators; c) use of other performance measures such as surveys, audits and feedback; d) the referencing of clinical performance indicators to evidence based medicine; e) encouragement for healthcare organisations to develop, implement or enrol in a quality indicators program. The standards require the evaluation and analysis of data from performance measurement and its use to improve performance and services. Data sources may include: a) indicators, patient/service user satisfaction assessments and other performance measures; b) complaints; and c) near misses, incidents and adverse events. a) Common legal and regulatory requirements that may be referenced relate to employment, health and safety, building, environmental protection, reportable diseases, waste management, food and hygiene, health professional registration, health information, medicines and technical standards. b) Health policy may relate to new public health initiatives based on latest research or evidence that have been issued as guidelines but not incorporated into law.

1.8

1.9

Law, regulations and health policy are recognised and integrated into the standards.

ISQuas International Principles for Healthcare Standards Third Edition

Criteria Principle 2

Revised Principles PATIENT/SERVICE USER FOCUS

Guidance

2.1

Standards are designed with a focus on patients/service users and reflect the patient/service user continuum of care or service. The standards cover the rights of patients/service users to: dignity and respect privacy confidentiality and safety and security. The standards require a system for receiving, investigating and resolving patient/service user complaints and concerns in a fair and timely way. The standards require staff to involve patients/service users in their own care and services by: respecting their preferences and choices; informing them about their options for care and treatment; and obtaining their informed consent.

Requirements could include organisations: a) documenting patient/service user rights and responsibilities; b) implementing training activities on them for staff.

2.2

2.3

Choices may include whether or not to be treated, the type of treatment, who they want involved in their care or service and end of life wishes. Preferences may relate to a) how they are addressed b) personal effects c) clothing and self care routines d) food, drink and meals e) activities, interests, privacy, visitors. Written consent is obtained for such activities as: a) participation in research or experimental procedures b) all operative and invasive procedures, anaesthesia and moderate/deep sedation and c) where there is a significant risk of adverse effects.

ISQuas International Principles for Healthcare Standards Third Edition

Criteria 2.4

Revised Principles The standards require the cultural and spiritual sensitivities of patients/ service users and their communities to be recognised.

Guidance This may include requirements to: a) provide access to spiritual care or advice that meets patients /service users needs; b) train staff on the cultural beliefs, needs and activities of different groups served; c) provide separate facilities and services for women and men where appropriate for the culture.

2.5

The standards cover access to services for patients/service users, including: a range of services based on the needs of the community and the scope of the organisation access for individuals with disabilities and special needs

2.6

coordinated admission or entry processes. The standards require that the Assessments may cover: assessments of patients/service a) patient/service user needs and users: risks appropriate to the type of are comprehensive service and patient/service user; involve relevant disciplines b) elements such as: are completed and documented in - medical a timely manner. - physical - mental, behavioural and emotional - nutritional - functional - pain - abuse and neglect. The standards require that individual care/service plans are prepared and documented: based on the assessment of patient/service user needs, including the results of diagnostic tests where relevant involving the patients/service users and their families including the goals or desired results of the treatment, care or service.

2.7

ISQuas International Principles for Healthcare Standards Third Edition

Criteria 2.8

Revised Principles The standards require that health professionals: follow the care/service plans monitor the progress of patients/ service users in achieving the goals or desired results of treatment, care or service reassess patients/service users needs when indicated revise the care/service plan according to results. The standards require that referral, transfer of care, discharge or end of service is planned.

Guidance

2.9

Requirements could include: a) planning commencing at first contact with the organisation and being ongoing; b) planning including patients/service users and their families; c) planning involving making links with referral agencies, other levels of health service and other organisations; d) if death is the expected outcome of the service, planning including the preparation of patients and their families for death, the management of pain and symptoms, linkage with support groups, counselling, and addressing spiritual and cultural needs.

Principle 3

ORGANISATIONAL PLANNING AND PERFORMANCE Standards assess the capacity and efficiency of healthcare organisations.

3.1

The standards require that Requirements could include: organisations use a planning process a) the plan considering the number of to determine the level of staffing and staff and independent practitioners skill mix required to meet the needs needed, the levels of seniority of the services provided. and experience required, and the different disciplines and roles to match the needs of services to be provided; b) the planning process being documented and able to be evidenced. 9

ISQuas International Principles for Healthcare Standards Third Edition

Criteria 3.2

Revised Principles The standards require that, for the positions they hold, staff, independent practitioners and volunteers where applicable, have relevant and current: orientation and training education knowledge skills and experience. The standards require that those permitted by law and by the organisation to practice are credentialed and have their scope of practice defined.

Guidance

3.3

Requirements could include: a) procedures for assessing or accepting healthcare professional training; b) credentials and scopes of practice being documented and regularly reviewed. Requirements could include competency assessments and performance evaluations being documented and shared with the staff member (or practitioner or volunteer) involved.

3.4

The standards require that staff, independent practitioners and volunteers where applicable: a) have their performance and competency evaluated on a regular basis b) receive relevant ongoing education and skill training and c) are provided with internal and external development opportunities. The standards require staff to follow current accepted standards, protocols and evidence based clinical practice guidelines. The standards require healthcare organisations to involve patients/ service users, their families, staff and where possible the wider community in planning for the provision of services.

3.5

3.6

Requirements could include the documentation of the planning process and those involved in it.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria 3.7

Revised Principles The standards require organisational planning to identify desired or expected service and organisational results and measure progress in achieving them.

Guidance Requirements could include: a) strategic and operational plans including longer term and short term goals and objectives for the organisation and its services; b) progress in achieving these goals and objectives through defined activities being measured and reported on a regular basis.

3.8

The standards require service planning to be based on the organisations strategic direction and to consider environmental and financial factors. The standards require the planning of functions, activities and the development of departments and services to include provisions for coordination with each other and with relevant external services. The standards require that the efficient use of resources is regularly reviewed and is evaluated against organisational plans and budgets. Reviews may include the utilisation of staff, equipment, supplies and space.

3.9

3.10

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria Principle 4

Revised Principles SAFETY Standards include measures to protect and improve the safety of patients/service users, staff and visitors to the organisation. The standards require a planned and structured approach to risk management that addresses all significant risks faced by the organisation and its services.

Guidance

4.1

A risk management plan may include elements such as: a) policy b) context c) scope and objectives and criteria for assessing risk d) risk management responsibilities and functions e) staff training f) a list of identified risks strategic, operational, financial and hazard g) a risk register or similar with an analysis of the risks and their level h) summary of risk treatment plans for major risks i) processes for communicating with stakeholders. Requirements could include the organisation: a) undertaking routine surveillance of actual performance compared with required performance; b) investigating the current situation and specific issues periodically; c) using results from the monitoring and review processes to make improvements. The system may include: a) training for staff b) means for documenting and reporting incidents/events c) root cause analysis d) processes for informing patients/ service users of adverse events.

4.2

The standards require the risk management plan to be monitored and reviewed for effectiveness and results communicated within the organisation.

4.3

The standards require healthcare organisations to have processes for reporting and investigating safety incidents, adverse events and near misses affecting patients/service users, staff or visitors and for using findings to improve services.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria 4.4

Revised Principles Guidance The standards require the The health and safety program for organisation to protect the health and staff needs to be appropriate to the safety of staff. risks in the particular care sector and may include: a) protective clothing and equipment for staff b) workplace assessments c) workload monitoring and stress management d) staff vaccination e) prevention from needlestick or manual handling injuries f) protection from occupational hazards. The standards require healthcare organisations to train staff on the safe operation of equipment, including medical devices, and ensure only trained and competent people handle specialised equipment. Standards require healthcare organisations to ensure that: relevant safety law and regulations are met the buildings, space, equipment and supplies necessary for the stated services are provided and facilities and equipment are inspected, tested, maintained and updated or replaced in a planned and systematic way. The standards require healthcare organisations to undertake clinical risk assessments to safeguard patients/service users from unintended consequences of care/ treatment. Risk assessments could be required to include: a) medication management, covering issues such as patient/service user allergies and antibiotic resistance; b) equipment risks, e.g. fire/injury risks from use of lasers; c) risks resulting from long term conditions.

4.5

4.6

4.7

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria 4.8

Revised Principles The standards require healthcare organisations to have a planned and systematic program for preventing and controlling infections which includes at least handwashing and cleaning requirements.

Guidance Other requirements may include, as appropriate to the care or services provided: a) structures and resources b) use of isolation and precaution techniques c) use of antibiotics d) sterilisation activities e) monitoring f) collection, analysis and use of infection event data g) reporting h) staff education. For acute services and others where applicable, this will include standards covering processes for: a) the safe management and use of blood and blood products b) right patient/right side/right site interventions c) safe practices before, during and after surgery, anaesthesia, moderate/deep sedation and invasive procedures d) safe medication management, including: - prescribing/ordering - transporting, storing and disposing - preventing, monitoring and documenting - responding promptly to adverse effects and medication errors.

4.9

The standards provide guidance to assist organisations to manage issues of patient/service user safety relevant to the care sector, including any appropriate safety priority areas from the WHO Global Patient Safety initiative.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria 4.10

Revised Principles The standards require patient/service user records to be current, complete, accurate and secure to assist the safety and continuity of care and treatment.

Guidance In the case of both electronic and hard copy records, requirements may include, as relevant to the service being provided: a) legible, dated, timely and signed entries b) alert notations c) progress notes, observations, consultation reports, diagnostic results d) all significant events such as alteration to patients/service users condition and responses to treatment and care e) any near misses, incidents or adverse events f) procedures for confidentiality, security and storage g) use of only recognised abbreviations h) procedures for retaining and destroying records.

Principle 5

STANDARDS DEVELOPMENT Standards are planned, formulated and evaluated through a defined and rigorous process. The need for new or revised standards and priorities are established by seeking the views of potential users, professional, purchaser, provider and patient/ service user groups and governments and other stakeholders and using evaluation data from the use of previous standards. Relationships with the standards of other organisations and professional and regulatory requirements are considered. Standards are developed or revised in accordance with a plan that includes objectives, resources and timeframes. Links or overlap with other standards may be identified to aid implementation of the standards and avoid duplication where possible.

5.1

5.2

5.3

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria 5.4

Revised Principles Standards are based on: current available research, evidence and experience internationally recognised guidelines recommendations from WHO and national/international professional organisations and input from technical experts and legal requirements. Government, professional, purchaser, provider and service user interests have adequate opportunity for input into the standards development and revision process through direct representation and formal consultation. The scope and purpose of the standards are clear in terms of: the type of healthcare organisation to which they apply; whether they are designed for use by a whole organisation; what range of services they cover; the reason the standards are needed and used. There is a clear framework for the standards that makes them easy for organisations and assessors to use.

Guidance Standards based on those of other organisations/countries could be adapted to local culture and health service requirements.

5.5

Opportunities for other interested parties to participate may include publication of draft standards for comment, such as posting on the internet.

5.6

The purpose or reason for the standards may be: a) to set a minimal level of acceptable performance b) to facilitate quality improvement c) for accreditation or certification d) for licensing or e) for insurance eligibility.

5.7

The framework may include: a) standards being grouped logically, e.g. by function or system; b) standards being labelled so that their content can be easily identified; c) the numbering system for the standards and their criteria or elements enabling them to be easily identified; d) A clear description of the standards framework in the documentation provided to users.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria 5.8

Revised Principles The wording of the standards is clear and unambiguous.

Guidance Clear wording may be achieved by: a) sentences having clear subjects and objects so it is clear what is required or who is responsible; b) words that may have more than one meaning or interpretation being clearly defined, e.g. good, well or sufficient; c) a formal review process to identify and clarify wording that is ambiguous or not clear; d) material being available to assist users in the interpretation of the standards.

5.9

Standards are tested/piloted and evaluated by providers and assessors prior to approval to ensure they are understandable, measurable, relevant and achievable. New and revised standards are approved by the standards setting body or appropriate authority before general implementation in the sector. There is a process to determine the Requirements may include: conditions under which the standards a) the process being documented; could be used by an independent b) expectations being defined and assessment organisation, other agreed, e.g. that the standards than the body that developed the are used as intended and that the standards. independent organisation provides feedback on the standards and the results of using them. Information and education are provided to users and assessors of the new and revised standards to enable interpretation and implementation. Parameters, timeframes and any transitional arrangement for the implementation of revised standards are clearly identified and followed. Requirements could include revisions of standards being publicised and distributed to users and assessors in sufficient time for them to develop an understanding of the standards before the date of implementation.

5.10

5.11

5.12

5.13

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria 5.14

Revised Principles The views on standards and the satisfaction of users, assessors and stakeholder groups with them are obtained, documented and monitored and the analysed data is evaluated to assist with improving standards.

Guidance Processes could include: a) feedback on the standards being sought from the organisation assessed and the assessors after assessments; b) periodic surveys of stakeholders being used to obtain their feedback on the standards; c) analysing feedback data on a regular basis, e.g. annually; d) using the data in the standards revision process in a way that can be demonstrated.

Principle 6

STANDARDS MEASUREMENT Standards enable consistent and transparent rating and measurement of achievement. There is a transparent system for rating an organisations performance on each standard, criterion or element. Guidelines or other information are provided to assist assessors to rate consistently and healthcare organisations to assess their own performance on the standards. There is a defined methodology for measuring overall achievement of a set of standards in a consistent way. Guidance may be provided on how criteria or standards are weighted or how ratings are to be applied where there are identified risks or safety issues. a) Examples of how the methodology may define achievement include achievement on all compulsory standards, or all standards being achieved at a defined level, or no standards being rated at below a defined level. b) The methodology may be used by organisations to assess their overall achievement of the standards as part of a selfassessment process. c) Overall performance on the standards may be used for the purposes of certification or accreditation, but these processes may use additional criteria that are not relevant here. 18

6.1

6.2

6.3

ISQuas International Principles for Healthcare Standards Third Edition

Criteria 6.4

Revised Principles The satisfaction of healthcare organisations and assessors with the measurement and rating system is evaluated and results used to make improvements.

Guidance Processes could include: a) feedback on the rating system obtained after the assessment from the organisation assessed and the assessors, e.g. its usefulness and ease of use; b) analysis of feedback data on a regular basis, e.g. annually; c) using the data to improve the rating system in a way that can be demonstrated.

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ISQuas International Principles for Healthcare Standards Third Edition

Attachment
The extent to which criteria from the 2nd edition Principles have been incorporated into the 3rd edition. Criterion/Topic 3rd edition Quality Improvement 3rd edition reference 1 1.1 1.2 2nd edition reference 1 1.1

Defined mission, values, ethics, strategic objectives Defined responsibilities for governance, management Information to public on services, quality Key policies, procedures plans Quality improvement system Key indicators/measures Defined responsibilities for quality improvement

3.1.5 + New 2.4 1.2

1.3 1.4 1.5 1.6 1.8 2 1.7 1.9

Data evaluation, analysis, use for improvement Integration of law, health policy Patient/Service User Focus

3.5.1, 3.5.2 New 1.4 2

1.3, 3.9.5

3.2.4

Patient/Service user rights Complaint system

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.1 3.3 3.5 3.4 3

3.7.1 3.2.3, 3.7.1, 3.7.2 3.1.1, 3.1.2, 3.1.3, 3.4.1 2.2, 3.5.1 3.2.1 3.1.4 3.7.4

Patient/Service user involvement in own care/services Cultural and spiritual sensitivity Access to services

Patient/Service user assessment

Patient/Service user care/service planning

Monitoring progress, revising care/service plans End of service planning Staff planning

2.2, 3.5.1, 3.6.2, 2.2, 3.4.3 New 3

Organisational Planning and Performance Orientation, skills and experience

Credentialling, defined scope of practice

3.2

Measurement of identified desired results

Involvement of patients/service users and staff in planning

Following standards, evidence based guidelines

Performance/competency evaluation, ongoing training

3.3.1 + New 3.2.2, 3.9.5 3.5.1 3.9.2 3.4.2 3.6.3 20 3.3.2, 3.9.3

3.3.1, 3.3.2

Service planning based on strategic direction

3.7 3.8 3.9

3.6

3.7.3, 3.9.1

Coordinated planning of activities and development

Efficient use of resources evaluated, plans and budgets

3.10

ISQuas International Principles for Healthcare Standards Third Edition

Planned risk management

Safety

Criterion/Topic 3rd edition

3rd edition reference 4 4.1 4.2 4.3 4.4 4.5 4.7 4.6 4.8 4.9 5

2nd edition reference 3 3.8.2 3.8.3 3.8.4 3.8.5 3.8.1, 3.8.3 New New New New 4.1.1 4.1.3 3.9.5, 4.1.4 2.1 + New New New 4.2.1 4.1.2 4 New

Risk management plan monitoring Staff health and safety protection Staff training on equipment Clinical risk assessment

Incident/Adverse event reporting/investigation system

Safety law, building and equipment safety Infection control program

Patient safety issues/priority safety areas Patient/Service user records Standards Development

4.10 5.1 5.2 5.3 5.5 5.7 5.8 5.10 5.12 5.13 6.1 6.2 6.3 6.4 6 5.11 5.9 5.6 5.4

Establishing need for new standards, priorities Standards development plan

Relationships with other standards considered Standards based on research, guidelines, technical input

Involvement of interested parties in development process Clear standards framework Clear wording of standards Clear scope and purpose of standards

Testing/Piloting of standards

Approval of standards by standards setting body

4.2.3 4.2.4 4.3.1 4.4.1, 4.4.2 5.1.1 5.1.2 5.2.1 5.3.1 5 4.3.2

Information and education to users and assessors

Timeframes, transitional arrangements for implementation Standards Measurement Satisfaction with standards monitored, data evaluated

Transparent rating system for standards, criteria Guidelines for users for consistent rating Defined methodology for measuring overall achievement Satisfaction of users with rating system evaluated

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