is quai ap principles v 3

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INTERNATIONALPRINCIPLES

FOR HEALTHCARE

STANDARDSThird Edition

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


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ISQuas International Principles for Healthcare Standards Third Edition

2

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 2ndedition 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 2ndedition 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 andwas 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.

3rdedition Principles

The 3rdedition contains six Principles compared with the ve Principles in the 2ndedition. The dimensions

of quality are no longer grouped within one Principle as in the 2ndedition 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 - 2007, ISQua The International Society for Quality in Health Care Inc. All rights reserved.

ABN: 31 936 709 889


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Organisational Planning and Performance:

Standards assess the capacity and efciency 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 dened and rigorous process

Standards Measurement:

Standards enable consistent and transparent rating and measurement of achievement.

Changes to 3rdedition from 2ndedition

New requirements for standards include:

the denition 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 identies the extent to which criteria from the 2ndedition Principles have been

incorporated into the 3rdedition.


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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 toassist 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 identied 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 January2008 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 2ndor 3rd edition of the Principles.

Criteria Revised Principles Guidance

Principle1

QUALITY IMPROVEMENT

Standards are designedto encourage healthcareorganisations to improve qualityand performance within theirown organisations and the widerhealthcare system.

1.1 The standards require healthcareorganisations to dene, asappropriate to their size and scope,

their:mission or purposevaluesethics or code of behaviour andstrategic objectives.

1.2 The standards dene responsibilitiesfor quality and performanceimprovement at different levels of theorganisation.

Responsibilities may be dened forgovernance, management, clinicians,other staff and, where applicable,volunteers.


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1.3 The standards dene theresponsibilities of a healthcareorganisation for:

governance andorganisational management.

Governance responsibilitiesa)may relate to determining theorganisations direction, settingobjectives and developing policy toguide the organisation in achieving

its 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 those

targets, allocating resourcesto accomplish those plans andensuring that plans are achievedby organizing, stafng, controllingand problem-solving.

1.4 The standards require healthcareorganisations 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 andplans for all key functions in theorganisation are

documentedauthorisedkept current andimplemented.

Authorisation may be demonstratedby the signature of a person withauthority to approve policies andplans, or the recorded decision of agoverning body.

1.6 The standards require an approachto 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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1.7 The standards require that key careand service processes and outcomesbe measured through the use of:

performance indicatorspatient/service user satisfaction

surveys/assessments andother performance measures.

Requirements could include:the use of these methods toa)measure functions such as humanresources, infection control, riskmanagement and patient/service

user care and services;encouragement of the use ofb)indicators expressed as ratioswith dened numerators anddenominators;use of other performancec)measures such as surveys, auditsand feedback;the referencing of clinicald)performance indicators to evidence

based medicine;encouragement for healthcaree)organisations to develop,implement or enrol in a qualityindicators program.

1.8 The standards require theevaluation and analysis of data fromperformance measurement and itsuse to improve performance andservices.

Data sources may include:indicators, patient/service usera)satisfaction assessments and otherperformance measures;complaints; andb)

near misses, incidents andc)adverse events.

1.9 Law, regulations and health policyare recognised and integrated intothe 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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Principle2

PATIENT/SERVICE USER FOCUS

Standards are designed with afocus on patients/service usersand reect the patient/service user

continuum of care or service.2.1 The standards cover the rights of

patients/service users to:dignity and respectprivacycondentiality andsafety and security.

Requirements could includeorganisations:

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

2.2 The standards require a system forreceiving, investigating and resolvingpatient/service user complaints and

concerns in a fair and timely way.

2.3 The standards require staff to involvepatients/service users in their owncare and services by:

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

Choices may include whether or notto be treated, the type of treatment,who they want involved in their care orservice 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 suchactivities as:

participation in research ora)experimental proceduresall operative and invasiveb)procedures, anaesthesia and

moderate/deep sedation andwhere there is a signicant risk ofc)adverse effects.


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2.4 The standards require the culturaland spiritual sensitivities of patients/service users and their communitiesto be recognised.

This may include requirements to:provide access to spiritual care ora)advice that meets patients /serviceusers needs;train staff on the cultural beliefs,b)

needs and activities of differentgroups served;provide separate facilities andc)services for women and menwhere appropriate for the culture.

2.5 The standards cover access toservices 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 theassessments of patients/serviceusers:

are comprehensive

involve relevant disciplinesare completed and documented ina timely manner.

Assessments may cover:patient/service user needs anda)risks appropriate to the type ofservice 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 individualcare/service plans are prepared anddocumented:

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

service.


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2.8 The standards require that healthprofessionals:

follow the care/service plansmonitor the progress of patients/service users in achieving the

goals 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 ofservice is planned.

Requirements could include:planning commencing at rsta)contact with the organisation and

being ongoing;planning including patients/serviceb)users and their families;planning involving making linksc)with referral agencies, otherlevels of health service and otherorganisations;if death is the expected outcome ofd)the service, planning including thepreparation of patients and theirfamilies for death, the management

of pain and symptoms, linkage withsupport groups, counselling, andaddressing spiritual and culturalneeds.

Principle3

ORGANISATIONAL PLANNINGAND PERFORMANCE

Standards assess the capacityand efciency of healthcare

organisations.

3.1 The standards require thatorganisations use a planning processto determine the level of stafngandskill mix required to meet the needsof the services provided.

Requirements could include:the plan considering the number ofa)staff and independent practitionersneeded, the levels of seniorityand experience required, and thedifferent disciplines and roles tomatch the needs of services to beprovided;the planning process beingb)

documented and able to beevidenced.


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3.2 The standards require that, forthe positions they hold, staff,independent practitioners andvolunteers where applicable, haverelevant and current:

orientation and trainingeducationknowledgeskills andexperience.

3.3 The standards require thatthose permitted by law and bythe organisation to practice arecredentialed and have their scope of

practice dened.

Requirements could include:procedures for assessing ora)accepting healthcare professionaltraining;

credentials and scopes of practiceb)being documented and regularlyreviewed.

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

have their performance anda)competency evaluated on aregular basisreceive relevant ongoingb)

education and skill training andare provided with internalc)and external developmentopportunities.

Requirements could includecompetency assessments andperformance evaluations beingdocumented and shared with the staffmember (or practitioner or volunteer)involved.

3.5 The standards require staff tofollow current accepted standards,protocols and evidence based clinicalpractice guidelines.

3.6 The standards require healthcareorganisations to involve patients/service users, their families, staff andwhere possible the wider communityin planning for the provision ofservices.

Requirements could include thedocumentation of the planningprocess and those involved in it.


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3.7 The standards require organisationalplanning to identify desired orexpected service and organisationalresults and measure progress inachieving them.

Requirements could include:strategic and operational plansa)including longer term and shortterm goals and objectives for theorganisation and its services;

progress in achieving these goalsb)and objectives through denedactivities being measured andreported on a regular basis.

3.8 The standards require serviceplanning to be based on theorganisations strategic directionand to consider environmental andnancial factors.

3.9 The standards require the planningof functions, activities and thedevelopment of departments andservices to include provisions forcoordination with each other andwith relevant external services.

3.10 The standards require that theefcient use of resources is regularlyreviewed and is evaluated againstorganisational plans and budgets.

Reviews may include the utilisation ofstaff, equipment, supplies and space.


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Principle4

SAFETY

Standards include measures toprotect and improve the safety ofpatients/service users, staff and

visitors to the organisation.

4.1 The standards require a plannedand structured approach to riskmanagement that addressesall signicant risks faced by theorganisation and its services.

A risk management plan may includeelements such as:

policya)contextb)scope and objectives and criteriac)for assessing riskrisk management responsibilitiesd)and functions

staff traininge)a list of identied risks strategic,f)operational, nancial 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 monitoredand reviewed for effectiveness andresults communicated within theorganisation.

Requirements could include the

organisation:undertaking routine surveillance ofa)actual performance compared withrequired performance;investigating the current situationb)and specic issues periodically;using results from the monitoringc)and review processes to makeimprovements.

4.3 The standards require healthcareorganisations to have processes forreporting and investigating safetyincidents, adverse events and nearmisses affecting patients/serviceusers, staff or visitors and for usingndings 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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4.4 The standards require theorganisation to protect the health andsafety of staff.

The health and safety program forstaff needs to be appropriate to therisks in the particular care sector andmay 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 healthcareorganisations to

train staff on the safe operationof equipment, including medicaldevices, andensure only trained andcompetent people handlespecialised equipment.

4.6 Standards require healthcareorganisations to ensure that:

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

4.7 The standards require healthcareorganisations to undertake clinicalrisk assessments to safeguardpatients/service users fromunintended consequences of care/treatment.

Risk assessments could be requiredto include:medication management, coveringa)issues such as patient/service userallergies and antibiotic resistance;equipment risks, e.g. re/injuryb)risks from use of lasers;risks resulting from long termc)conditions.


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4.8 The standards require healthcareorganisations to have a planned andsystematic program for preventingand controlling infections whichincludes at least handwashing and

cleaning requirements.

Other requirements may include, asappropriate to the care or servicesprovided:

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 manageissues of patient/service user safetyrelevant to the care sector, includingany appropriate safety priority areasfrom the WHO Global Patient Safetyinitiative.

For acute services and others where

applicable, this will include standardscovering 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 andinvasive proceduressafe medication management,d)

including:prescribing/ordering-transporting, storing and-disposingpreventing, monitoring and-documentingresponding promptly to adverse-effects and medication errors.


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4.10 The standards require patient/serviceuser records to be current, complete,accurate and secure to assist thesafety and continuity of care andtreatment.

In the case of both electronic andhard copy records, requirements mayinclude, as relevant to the servicebeing provided:

legible, dated, timely and signeda)

entriesalert notationsb)progress notes, observations,c)consultation reports, diagnosticresultsall signicant events such asd)alteration to patients/serviceusers condition and responses totreatment and careany near misses, incidents ore)

adverse eventsprocedures for condentiality,f)security and storageuse of only recognisedg)abbreviationsprocedures for retaining andh)destroying records.

Principle5

STANDARDS DEVELOPMENT

Standards are planned, formulated

and evaluated through a denedand rigorous process.

5.1 The need for new or revisedstandards and priorities areestablished by seeking the viewsof potential users, professional,purchaser, provider and patient/service user groups andgovernments and other stakeholders

and using evaluation data from theuse of previous standards.

5.2 Relationships with the standards ofother organisations and professionaland regulatory requirements areconsidered.

Links or overlap with otherstandards may be identied to aidimplementation of the standards andavoid duplication where possible.

5.3 Standards are developed or revisedin accordance with a plan thatincludes objectives, resources and

timeframes.


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5.4 Standards are based on:current available research,evidence and experienceinternationally recognisedguidelines

recommendations from WHO andnational/international professionalorganisations andinput from technical experts andlegal requirements.

Standards based on those of otherorganisations/countries could beadapted to local culture and healthservice requirements.

5.5 Government, professional,purchaser, provider and service userinterests have adequate opportunityfor input into the standards

development and revision processthrough direct representation andformal consultation.

Opportunities for other interestedparties to participate may includepublication of draft standards forcomment, such as posting on the

internet.

5.6 The scope and purpose of thestandards 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 they

cover;the reason the standards areneeded and used.

The purpose or reason for thestandards may be:

to set a minimal level of acceptablea)performanceto facilitate quality improvementb)for accreditation or certicationc)for licensing ord)

for insurance eligibility.e)

5.7 There is a clear framework for thestandards that makes them easy fororganisations 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 easilyidentied;

the numbering system for thec) standards and their criteria orelements enabling them to beeasily identied;A clear description of the standardsd)framework in the documentationprovided to users.


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5.8 The wording of the standards is clearand unambiguous.

Clear wording may be achieved by:sentences having clear subjectsa)and objects so it is clear what isrequired or who is responsible;words that may have more thanb)

one meaning or interpretationbeing clearly dened, e.g. good,well or sufcient;a formal review process toc)identify and clarify wording that isambiguous or not clear;material being available to assistd)users in the interpretation of thestandards.

5.9 Standards are tested/pilotedand evaluated by providers andassessors prior to approval toensure they are understandable,measurable, relevant and achievable.

5.10 New and revised standards areapproved by the standards settingbody or appropriate authority beforegeneral implementation in the sector.

5.11 There is a process to determine theconditions under which the standardscould be used by an independentassessment organisation, otherthan the body that developed thestandards.

Requirements may include:the process being documented;a)expectations being dened 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 assessorsof the new and revised standardsto enable interpretation andimplementation.

5.13 Parameters, timeframes and anytransitional arrangement for theimplementation of revised standardsare clearly identied and followed.

Requirements could include revisionsof standards being publicised anddistributed to users and assessors insufcient time for them to develop anunderstanding of the standards beforethe date of implementation.


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5.14 The views on standards and thesatisfaction of users, assessors andstakeholder groups with them areobtained, documented and monitoredand the analysed data is evaluated to

assist with improving standards.

Processes could include:a) feedback on the standards being

sought from the organisationassessed and the assessors afterassessments;

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

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

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

Principle

6

STANDARDS MEASUREMENT

Standards enable consistentand transparent rating andmeasurement of achievement.

6.1 There is a transparent system forrating an organisations performanceon each standard, criterion orelement.

6.2 Guidelines or other informationare provided to assist assessorsto rate consistently and healthcareorganisations to assess their ownperformance on the standards.

Guidance may be provided on howcriteria or standards are weighted orhow ratings are to be applied wherethere are identied risks or safetyissues.

6.3 There is a dened methodology formeasuring overall achievement of aset of standards in a consistent way.

Examples of how the methodologya)may dene achievement includeachievement on all compulsorystandards, or all standards beingachieved at a dened level, or no

standards being rated at below adened 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 certication oraccreditation, but these processes

may use additional criteria that arenot relevant here.


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6.4 The satisfaction of healthcareorganisations and assessors with themeasurement and rating system isevaluated and results used to makeimprovements.

Processes could include:feedback on the rating systema)obtained after the assessmentfrom the organisation assessedand 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 bedemonstrated.


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Attachment

The extent to which criteria from the 2ndedition Principles have been incorporated into the 3rdedition.

Criterion/Topic

3rdedition

3rdedition

reference

2ndedition

reference

Quality Improvement 1 1

Dened mission, values, ethics, strategic objectives 1.1 3.1.5 + New

Dened responsibilities for quality improvement 1.2 1.1

Dened responsibilities for governance, management 1.3 2.4

Information to public on services, quality 1.4 1.2

Key policies, procedures plans 1.5 3.2.4

Quality improvement system 1.6 1.3, 3.9.5

Key indicators/measures 1.7 3.5.1, 3.5.2Data evaluation, analysis, use for improvement 1.8 New

Integration of law, health policy 1.9 1.4

Patient/Service User Focus 2 2

Patient/Service user rights 2.1 3.7.1

Complaint system 2.2 3.7.4

Patient/Service user involvement in own care/services 2.3 3.2.3, 3.7.1,3.7.2

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

3.1.3, 3.4.1

Patient/Service user assessment 2.6 3.2.1

Patient/Service user care/service planning 2.7 2.2, 3.5.1

Monitoring progress, revising care/service plans 2.8 2.2, 3.5.1,3.6.2,

End of service planning 2.9 2.2, 3.4.3

Organisational Planning and Performance 3 3

Staff planning 3.1 New

Orientation, skills and experience 3.2 3.3.1, 3.3.2

Credentialling, dened scope of practice 3.3 3.3.1 + New

Performance/competency evaluation, ongoing training 3.4 3.3.2, 3.9.3

Following standards, evidence based guidelines 3.5 3.2.2, 3.9.5

Involvement of patients/service users and staff in planning 3.6 3.7.3, 3.9.1

Measurement of identied desired results 3.7 3.5.1

Service planning based on strategic direction 3.8 3.9.2

Coordinated planning of activities and development 3.9 3.4.2Efcient use of resources evaluated, plans and budgets 3.10 3.6.3


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Criterion/Topic3rdedition

3rdeditionreference

2ndeditionreference

Safety 4 3

Planned risk management 4.1 3.8.2

Risk management plan monitoring 4.2 3.8.3

Incident/Adverse event reporting/investigation system 4.3 3.8.4

Staff health and safety protection 4.4 3.8.5

Staff training on equipment 4.5 New

Safety law, building and equipment safety 4.6 3.8.1, 3.8.3

Clinical risk assessment 4.7 New

Infection control program 4.8 New

Patient safety issues/priority safety areas 4.9 New

Patient/Service user records 4.10 New

Standards Development 5 4

Establishing need for new standards, priorities 5.1 4.1.1

Relationships with other standards considered 5.2 4.1.3

Standards development plan 5.3 4.1.2

Standards based on research, guidelines, technical input 5.4 3.9.5, 4.1.4

Involvement of interested parties in development process 5.5 4.2.1

Clear scope and purpose of standards 5.6 2.1 + New

Clear standards framework 5.7 New

Clear wording of standards 5.8 NewTesting/Piloting of standards 5.9 4.2.3

Approval of standards by standards setting body 5.10 4.2.4

Information and education to users and assessors 5.11 4.3.1

Timeframes, transitional arrangements for implementation 5.12 4.3.2

Satisfaction with standards monitored, data evaluated 5.13 4.4.1, 4.4.2

Standards Measurement 6 5

Transparent rating system for standards, criteria 6.1 5.1.1

Guidelines for users for consistent rating 6.2 5.1.2Dened methodology for measuring overall achievement 6.3 5.2.1

Satisfaction of users with rating system evaluated 6.4 5.3.1

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