international principles for healthcare standards b

INTERNATIONAL

PRINCIPLES

FOR HEALTHCARE

STANDARDS

Third Edition

A FRAMEWORK OF REQUIREMENTS FOR STANDARDS

Published by The International Society for Quality in Health Care December 20073rd Floor, Joyce House, 8-11 Lombard Street East, Dublin 2, Ireland

ISQuas International Principles for Healthcare Standards Third Edition

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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 rst 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 reect 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 rst 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 ve 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 reected 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 reect the patient/service user continuum of care or service

Copyright 2000 - 2011, ISQua The International Society for Quality in Health Care. All rights reserved.


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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 previousPrinciple 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.


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ISQua Standards Assessment ProcessOn 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 Revised Principles GuidancePrinciple 1

QUALITY IMPROVEMENTStandards are designed to encourage healthcare organisations to improve quality and performance within their own organisations and the wider healthcare system.

1.1 The standards require healthcare organisations to define, as appropriate to their size and scope, their:

mission or purposevaluesethics or code of behaviour andstrategic objectives.

1.2 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.


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Criteria Revised Principles Guidance1.3 The standards define the

responsibilities of a healthcare organisation for:

governance andorganisational management.

Governance responsibilitiesa)may relate to determining theorganisations direction, settingobjectives and developing policy toguide the organisation in achievingits mission, and monitoring theachievement of those objectivesand the implementation of policy.Organisational managementb)responsibilities may relate tosetting targets or goals for thefuture through planning andbudgeting for the organisationsrange of services, establishingprocesses for achieving thosetargets, allocating resourcesto accomplish those plans andensuring that plans are achievedby organizing, staffing, controllingand problem-solving.

1.4 The standards require healthcare organisations to inform the public of:

the services they provide andthe quality and performance ofthe services.

1.5 The standards require that policies, procedures or processes and plans for all key functions in the organisation are

documentedauthorisedkept current andimplemented.

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.

1.6 The standards require an approach to quality improvement that:

is systematicis continuousis organisation-widecovers all aspects of performancesupports innovationincorporates monitoring, includingof all high risk processes andprocedures, and evaluation.


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Criteria Revised Principles Guidance1.7 The standards require that key care

and service processes and outcomes be measured through the use of:

performance indicatorspatient/service user satisfactionsurveys/assessments andother performance measures.

Requirements could include:the use of these methods toa)measure functions such as human resources, infection control, risk management and patient/service user care and services; encouragement of the use ofb)indicators expressed as ratios with defined numerators and denominators; use of other performancec)measures such as surveys, audits and feedback;the referencing of clinicald)performance indicators to evidence based medicine;encouragement for healthcaree)organisations to develop, implement or enrol in a quality indicators program.

1.8 The standards require the evaluation and analysis of data from performance measurement and its use to improve performance and services.

Data sources may include:indicators, patient/service usera)satisfaction assessments and other performance measures;complaints; andb)near misses, incidents andc)adverse events.

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

Common legal and regulatorya)requirements that may bereferenced relate to employment,health and safety, building,environmental protection,reportable diseases, wastemanagement, food and hygiene,health professional registration,health information, medicines andtechnical standards.Health policy may relate to newb)public health initiatives based onlatest research or evidence thathave been issued as guidelines butnot incorporated into law.


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PATIENT/SERVICE USER FOCUSStandards are designed with a focus on patients/service users and reflect the patient/service user continuum of care or service.

2.1 The standards cover the rights of patients/service users to:

dignity and respectprivacyconfidentiality andsafety and security.

Requirements could include organisations:

documenting patient/service usera)rights and responsibilities;implementing training activities onb)them for staff.

2.2 The standards require a system for receiving, investigating and resolving patient/service user complaints and concerns in a fair and timely way.

2.3 The standards require staff to involve patients/service users in their own care and services by:

respecting their preferences andchoices;informing them about their optionsfor care and treatment; andobtaining their informed consent.

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 tohow they are addresseda)personal effectsb)clothing and self care routinesc)food, drink and mealsd)activities, interests, privacy,e)visitors.

Written consent is obtained for such activities as:

participation in research ora)experimental proceduresall operative and invasiveb)procedures, anaesthesia and moderate/deep sedation and where there is a significant risk ofc)adverse effects.


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Criteria Revised Principles Guidance2.4 The standards require the cultural

and spiritual sensitivities of patients/service users and their communities to be recognised.

This may include requirements to:provide access to spiritual care ora)advice that meets patients /service users needs;train staff on the cultural beliefs,b)needs and activities of different groups served;provide separate facilities andc)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 communityand the scope of the organisation

access for individuals withdisabilities and special needs

coordinated admission or entryprocesses.

2.6 The standards require that the assessments of patients/service users:

are comprehensiveinvolve relevant disciplinesare completed and documented ina timely manner.

Assessments may cover:patient/service user needs anda)risks appropriate to the type of service and patient/service user; elements such as:b)

medical- physical- mental, behavioural and - emotionalnutritional- functional- pain- abuse and neglect.-

2.7 The standards require that individual care/service plans are prepared and documented:

based on the assessment ofpatient/service user needs, including the results of diagnostic tests where relevantinvolving the patients/serviceusers and their familiesincluding the goals or desiredresults of the treatment, care or service.


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Criteria Revised Principles Guidance2.8 The standards require that health

professionals:follow the care/service plansmonitor the progress of patients/service users in achieving thegoals or desired results oftreatment, care or servicereassess patients/service usersneeds when indicatedrevise the care/service planaccording to results.

2.9 The standards require that referral, transfer of care, discharge or end of service is planned.

Requirements could include:planning commencing at firsta)contact with the organisation and being ongoing;planning including patients/serviceb)users and their families;planning involving making linksc)with referral agencies, other levels of health service and other organisations;if death is the expected outcome ofd)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 organisations use a planning process to determine the level of staffing and skill mix required to meet the needs of the services provided.

Requirements could include:the plan considering the number ofa)staff and independent practitioners needed, the levels of seniority and experience required, and the different disciplines and roles to match the needs of services to be provided; the planning process beingb)documented and able to be evidenced.


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Criteria Revised Principles Guidance3.2 The standards require that, for

the positions they hold, staff, independent practitioners and volunteers where applicable, have relevant and current:

orientation and trainingeducationknowledgeskills andexperience.

3.3 The standards require that those permitted by law and by the organisation to practice are credentialed and have their scope of practice defined.

Requirements could include:procedures for assessing ora)accepting healthcare professional training;credentials and scopes of practiceb)being documented and regularly reviewed.

3.4 The standards require that staff, independent practitioners and volunteers where applicable:

have their performance anda)competency evaluated on a regular basis receive relevant ongoingb)education and skill training andare provided with internalc)and external development opportunities.

Requirements could include competency assessments and performance evaluations being documented and shared with the staff member (or practitioner or volunteer) involved.

3.5 The standards require staff to follow current accepted standards, protocols and evidence based clinical practice guidelines.

3.6 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.

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


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Criteria Revised Principles Guidance3.7 The standards require organisational

planning to identify desired or expected service and organisational results and measure progress in achieving them.

Requirements could include:strategic and operational plansa)including longer term and short term goals and objectives for the organisation and its services; progress in achieving these goalsb)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.

3.9 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.

3.10 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.


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SAFETY

Standards include measures to protect and improve the safety of patients/service users, staff and visitors to the organisation.

4.1 The standards require a planned and structured approach to risk management that addresses all significant risks faced by the organisation and its services.

A risk management plan may include elements such as:

policya)contextb)scope and objectives and criteriac)for assessing riskrisk management responsibilitiesd)and functionsstaff traininge)a list of identified risks strategic,f)operational, financial and hazarda risk register or similar with ang)analysis of the risks and their levelsummary of risk treatment plansh)for major risksprocesses for communicating withi)stakeholders.

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

Requirements could include the organisation:

undertaking routine surveillance ofa)actual performance compared with required performance;investigating the current situationb)and specific issues periodically;using results from the monitoringc)and review processes to make improvements.

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.

The system may include:training for staffa)means for documenting andb)reporting incidents/eventsroot cause analysisc)processes for informing patients/d)service users of adverse events.


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Criteria Revised Principles Guidance4.4 The standards require the

organisation to protect the health and safety of staff.

The health and safety program for staff needs to be appropriate to the risks in the particular care sector and may include:

protective clothing and equipmenta)for staffworkplace assessmentsb)workload monitoring and stressc)managementstaff vaccinationd)prevention from needlestick ore)manual handling injuriesprotection from occupationalf)hazards.

4.5 The standards require healthcare organisations to

train staff on the safe operationof equipment, including medical devices, and ensure only trained andcompetent people handle specialised equipment.

4.6 Standards require healthcare organisations to ensure that:

relevant safety law andregulations are metthe buildings, space, equipmentand supplies necessary for the stated services are provided andfacilities and equipment areinspected, tested, maintained and updated or replaced in a planned and systematic way.

4.7 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:

medication management, coveringa)issues such as patient/service user allergies and antibiotic resistance;equipment risks, e.g. fire/injuryb)risks from use of lasers;risks resulting from long termc)conditions.


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Criteria Revised Principles Guidance4.8 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.

Other requirements may include, as appropriate to the care or services provided:

structures and resourcesa)use of isolation and precautionb)techniquesuse of antibioticsc)sterilisation activitiesd)monitoringe)collection, analysis and use off)infection event datareportingg)staff education.h)

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.

For acute services and others where applicable, this will include standards covering processes for:

the safe management and use ofa)blood and blood productsright patient/right side/right siteb)interventionssafe practices before, duringc)and after surgery, anaesthesia, moderate/deep sedation and invasive proceduressafe medication management,d)including:

prescribing/ordering- transporting, storing and - disposingpreventing, monitoring and - documenting responding promptly to adverse - effects and medication errors.


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Criteria Revised Principles Guidance4.10 The standards require patient/service

user records to be current, complete, accurate and secure to assist the safety and continuity of care and treatment.

In the case of both electronic and hard copy records, requirements may include, as relevant to the service being provided:

legible, dated, timely and signeda)entriesalert notationsb)progress notes, observations,c)consultation reports, diagnosticresultsall significant events such asd)alteration to patients/serviceusers condition and responses totreatment and careany near misses, incidents ore)adverse eventsprocedures for confidentiality,f)security and storageuse of only recognisedg)abbreviationsprocedures for retaining andh)destroying records.

Principle 5

STANDARDS DEVELOPMENT

Standards are planned, formulated and evaluated through a defined and rigorous process.

5.1 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.

5.2 Relationships with the standards of other organisations and professional and regulatory requirements are considered.

Links or overlap with other standards may be identified to aid implementation of the standards and avoid duplication where possible.

5.3 Standards are developed or revised in accordance with a plan that includes objectives, resources and timeframes.


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Criteria Revised Principles Guidance5.4 Standards are based on:

current available research,evidence and experienceinternationally recognisedguidelinesrecommendations from WHO andnational/international professional organisations andinput from technical experts andlegal requirements.

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

5.5 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.

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

5.6 The scope and purpose of the standards are clear in terms of:

the type of healthcareorganisation to which they apply; whether they are designed for useby a whole organisation; what range of services theycover;the reason the standards areneeded and used.

The purpose or reason for the standards may be:

to set a minimal level of acceptablea)performance to facilitate quality improvementb)for accreditation or certificationc)for licensing ord)for insurance eligibility.e)

5.7 There is a clear framework for the standards that makes them easy for organisations and assessors to use.

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


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Criteria Revised Principles Guidance5.8 The wording of the standards is clear

and unambiguous.Clear wording may be achieved by:

sentences having clear subjectsa)and objects so it is clear what is required or who is responsible;words that may have more thanb)one meaning or interpretation being clearly defined, e.g. good, well or sufficient;a formal review process toc)identify and clarify wording that is ambiguous or not clear;material being available to assistd)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.

5.10 New and revised standards are approved by the standards setting body or appropriate authority before general implementation in the sector.

5.11 There is a process to determine the conditions under which the standards could be used by an independent assessment organisation, other than the body that developed the standards.

Requirements may include:the process being documented;a)expectations being defined andb)agreed, e.g. that the standardsare used as intended and that theindependent organisation providesfeedback on the standards and theresults of using them.

5.12 Information and education are provided to users and assessors of the new and revised standards to enable interpretation and implementation.

5.13 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.


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Criteria Revised Principles Guidance5.14 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.

Processes could include:a) feedback on the standards being

sought from the organisation assessed and the assessors after assessments;

b) periodic surveys of stakeholdersbeing used to obtain their feedback on the standards;

c) analysing feedback data on aregular basis, e.g. annually;

d) using the data in the standardsrevision process in a way that can be demonstrated.

Principle 6

STANDARDS MEASUREMENT

Standards enable consistent and transparent rating and measurement of achievement.

6.1 There is a transparent system for rating an organisations performance on each standard, criterion or element.

6.2 Guidelines or other information are provided to assist assessors to rate consistently and healthcare organisations to assess their own performance on the standards.

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.

6.3 There is a defined methodology for measuring overall achievement of a set of standards in a consistent way.

Examples of how the methodologya)may define achievement includeachievement on all compulsorystandards, or all standards beingachieved at a defined level, or nostandards being rated at below adefined level.The methodology may be usedb)by organisations to assesstheir overall achievement ofthe standards as part of a self-assessment process.Overall performance on thec)standards may be used forthe purposes of certification oraccreditation, but these processesmay use additional criteria that arenot relevant here.


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Criteria Revised Principles Guidance6.4 The satisfaction of healthcare

organisations and assessors with the measurement and rating system is evaluated and results used to make improvements.

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


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AttachmentThe extent to which criteria from the 2nd edition Principles have been incorporated into the 3rd edition.

Criterion/Topic3rd edition

3rd editionreference

2nd edition reference

Quality Improvement 1 1Defined mission, values, ethics, strategic objectives 1.1 3.1.5 + NewDefined responsibilities for quality improvement 1.2 1.1Defined responsibilities for governance, management 1.3 2.4Information to public on services, quality 1.4 1.2Key policies, procedures plans 1.5 3.2.4Quality improvement system 1.6 1.3, 3.9.5Key indicators/measures 1.7 3.5.1, 3.5.2Data evaluation, analysis, use for improvement 1.8 NewIntegration of law, health policy 1.9 1.4Patient/Service User Focus 2 2Patient/Service user rights 2.1 3.7.1Complaint system 2.2 3.7.4Patient/Service user involvement in own care/services 2.3 3.2.3, 3.7.1,

3.7.2Cultural and spiritual sensitivity 2.4 3.1.4Access to services 2.5 3.1.1, 3.1.2,

3.1.3, 3.4.1Patient/Service user assessment 2.6 3.2.1Patient/Service user care/service planning 2.7 2.2, 3.5.1Monitoring progress, revising care/service plans 2.8 2.2, 3.5.1,

3.6.2, End of service planning 2.9 2.2, 3.4.3Organisational Planning and Performance 3 3Staff planning 3.1 NewOrientation, skills and experience 3.2 3.3.1, 3.3.2Credentialling, defined scope of practice 3.3 3.3.1 + NewPerformance/competency evaluation, ongoing training 3.4 3.3.2, 3.9.3Following standards, evidence based guidelines 3.5 3.2.2, 3.9.5Involvement of patients/service users and staff in planning 3.6 3.7.3, 3.9.1Measurement of identified desired results 3.7 3.5.1Service planning based on strategic direction 3.8 3.9.2Coordinated planning of activities and development 3.9 3.4.2Efficient use of resources evaluated, plans and budgets 3.10 3.6.3


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Criterion/Topic3rd edition

3rd editionreference

2nd edition reference

Safety 4 3Planned risk management 4.1 3.8.2Risk management plan monitoring 4.2 3.8.3Incident/Adverse event reporting/investigation system 4.3 3.8.4Staff health and safety protection 4.4 3.8.5Staff training on equipment 4.5 NewSafety law, building and equipment safety 4.6 3.8.1, 3.8.3Clinical risk assessment 4.7 NewInfection control program 4.8 NewPatient safety issues/priority safety areas 4.9 NewPatient/Service user records 4.10 NewStandards Development 5 4Establishing need for new standards, priorities 5.1 4.1.1Relationships with other standards considered 5.2 4.1.3Standards development plan 5.3 4.1.2Standards based on research, guidelines, technical input 5.4 3.9.5, 4.1.4Involvement of interested parties in development process 5.5 4.2.1Clear scope and purpose of standards 5.6 2.1 + NewClear standards framework 5.7 NewClear wording of standards 5.8 NewTesting/Piloting of standards 5.9 4.2.3Approval of standards by standards setting body 5.10 4.2.4Information and education to users and assessors 5.11 4.3.1Timeframes, transitional arrangements for implementation 5.12 4.3.2Satisfaction with standards monitored, data evaluated 5.13 4.4.1, 4.4.2Standards Measurement 6 5Transparent rating system for standards, criteria 6.1 5.1.1Guidelines for users for consistent rating 6.2 5.1.2Defined methodology for measuring overall achievement 6.3 5.2.1Satisfaction of users with rating system evaluated 6.4 5.3.1

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