Accreditation of Inspection health and social care in the UK

Paul Stennett, Chief Executive Officer, UKAS

World Accreditation Day 2015

Introduction to UKAS

• UKAS established in 1995 as a non-profit distributing

private company limited by guarantee

• Originated in 1966; 49 years of accreditation experience

• The UK’s national accreditation body; European Union

Regulation gives a legal framework and requirement for

accreditation throughout Europe

• The performance of UKAS is monitored by the UK

Government and peer-assessed internationally

“Procedure by which an authoritative body gives

formal recognition that an organisation is competent to

carry out specific tasks”

• Independent & impartial assessment by competent

authoritative third party – an accreditation body

• Demonstration of technical competence, integrity &

impartiality

• Gives confidence to all users and reduces risk

What is accreditation?

UKAS and Healthcare accreditation

• The first accreditation scheme for medical (pathology)

laboratories in the UK, was launched in 1992 by

Clinical Pathology Accreditation (“CPA”).

• CPA was established by the medical and clinical

professionals in the UK who developed the CPA

standard.

• The CPA standard provided much of the basis for ISO

15189.

• CPA merged with UKAS in 2009.

UKAS accreditation for Diagnostics

and Scientific Services

• Medical Laboratories ISO 15189

• Point of care testing ISO 15189 and 22870

• EQA Providers ISO 17043

• Physiological diagnostics

• Imaging Services Accreditation Scheme

• Medical Devices ISO 13485

• Hospital QM schemes (ISO 9000)

• Public Health laboratories(ISO15189 & 17025)

• Medical Physics and engineering (ISO 15189)

( under development)

UKAS Accreditation – essential ingredients

• Delivered in accordance with international

standards that are mutually recognised

• Defined requirements for competence of bodies

seeking/gaining accreditation

• Rigorous independent, impartial assessment

process conducted by competent peer assessors

• Independent decision making

• Access to stakeholder expertise and input

UKAS Accreditation – recent developments

• In the UK, UKAS is accrediting most of the major

“diagnostics areas” to ISO15189

• UKAS also accredits EQA (“Proficiency Testing”)

schemes and general hospital quality

management schemes ( based on ISO9000)

• Recent requests have been received for Adult

residential care homes and caring for the dying

schemes

Accreditation underpinning healthcare services

UKAS

AccreditationISO/IEC 17011

Organisations that conduct Evaluations or ‘Conformity

Assessment’

Certification or Inspection (ISO/IEC 17065 or 17020)

Testing/Diagnostic and measurement services

(ISO 15189, 17025 or equivalent e.g. ISAS/IQIPS)

Service that includes taking

and testing of samples

e.g. Blood/biopsies

Service that includes the

identification of a disease

or characteristic Process or service

e.g. care pathway,

dental serviceDefined Clinical Service

standard

The Patient

• Consider the activity - is the clinical service, or a

significant component, considered to be conformity

assessment?

• Consider the criteria for competence - does existing

criteria exist? Does this identify the type of recognition?

• Consider the status of the assessing body - what is

their function, what recognition do they provide? What

standards do they work to? Independent and impartial?

• Consider the assessment process – type of

assessment, competence of assessors, framework within

which it is delivered, level of rigour, frequency

there may be more than one option!

Accreditation, Certification or Inspection?

Accreditation Certification Inspection

Relevant international standard (or

mapped equivalent) used as criteria

used for accreditation e.g. ISO/IEC

15189, ISAS standard

Used for attesting the competence of

evaluation or ‘conformity assessment’

bodies

Assessment conducted in accordance

with EU Regulation and ISO/IEC 17011

Delivered by the national accreditation

body (UKAS)

Assessment of scope of activities using

trained competent peer assessors

On site Initial assessment followed by

annual surveillance activity and full

reassessment every 4 years

Cannot rely on self-assessment

Recognised internationally where

mutual recognition arrangements exist

Recognised by UK Government as the

highest level of control in the

conformity assessment chain

Audit of system, process or service by

an independent third party

Certification standard can be an

international standard or stakeholder

developed standard/scheme

‘Certification Body’ can have

competence recognised to perform

audits by accreditation (ISO/IEC 17065)

Certification will be awarded on an on-

going basis and certified service will

require periodic

surveillance/recertification audits

Trained and authorised auditors used

with defined competence – may not

need to be full peer assessment as

required by the scheme

Objectives of certification must be

defined and compliance demonstrated

before certification awarded

Multiple certification bodies can be

used, or a single body – accreditation

can be used to ensure consistency

UKAS accredited certification is

recognised by UK government and also

internationally where relevant mutual

recognition arrangements exist

Inspection of a system, process or

service by an impartial body (differing

levels of independence are defined)

Inspection standard needs to be

defined and accepted by relevant

stakeholders

‘Inspection Body’ can have

competence recognised to perform

inspections by accreditation (ISO/IEC

17020

Can be used for one-off, ad-hoc

evaluation as well as on-going

scheduled regime

Trained and authorised inspectors used

with defined competence – may not

need to be full peer assessment as

required by the scheme

Objectives of inspection process must

be defined

Can be used where an incremental

quality improvement is needed

Multiple inspection bodies can be

used, or a single body – accreditation

can be used to ensure consistency

UKAS accredited inspection is

recognised by UK government and also

internationally where relevant mutual

recognition arrangements exist

Standards of competence for bodies conducting

assessments of Clinical Services

• Currently a variety of approaches – direct accreditation

and certification/inspection

• No need to develop criteria for these bodies – there are

existing international standards

• Guidance could be developed to support the international

standards

• Specific requirements could be identified to apply to UKAS

and other assessment bodies e.g. use of lay assessors to

assess clinical service

Developing accreditation and standards

How accreditation works

Requirements

of accreditation

Impartiality, integrity,

independence

Competence

Appropriate resources and

facilities

Performance demonstrated to

be to required standard

Capable of sustaining the

required level of performance

Who conducts the assessment?

• Competence criteria defined for assessors

• Competent Peer Assessor(s) used to cover

repertoire/scope of service

• Lead Assessor – UKAS Assessment Manager

• Lay assessors

• All assessors trained and authorised by UKAS

• All assessors monitored and evaluated to ensure

competence is maintained

UKAS – Inspection & Social Care

UKAS is developing accreditation for inspection of health and social

care services using the accreditation standard ISO / IEC 17020:2012.

ISO 17020 states that inspection can be to “provide information with

no determination of conformity”

Three separate pilot assessment programmes are currently underway

for,

Accreditation of inspection of care providers by independent

inspection bodies.

Accreditation of reviews of healthcare services provided by the UK

National Health Service (“NHS”) healthcare providers.

Accreditation of inspection of caring for the dying ( in the last hours

and days).

Accreditation of inspection of care homes by

independent inspection bodies

• There are around 30,000 care homes as well as other types

of care providers in the UK and these are inspected by

regulatory bodies in England, Scotland, Wales and Northern

Ireland for regulatory compliance.

• There are also a number of private inspection bodies

operating in the UK that provide inspection services to care

homes and care providers.

• The private inspection bodies assist care homes to improve

the quality of care, to prepare for regulatory compliance

where applicable, and in some cases for awarding star

ratings to recognise achievement of inspection standards.

Accreditation of inspection of care homes

by independent inspection bodies cont..

• UKAS has considered that the accreditation of inspection of

care homes by private inspection bodies is in the public

interest and in 2014 announced the initiation of a pilot

assessment programme.

• Following a process of consultation with interested applicants

and stakeholders, 3 applicants were selected for piloting the

UKAS assessment process for accrediting inspection of adult

social care using the standard ISO/ IEC 17020:2012

(Conformity assessment – Requirements for operation of

various types of inspection bodies).

Accreditation of Inspection etc – some issues

• These observations are based on early experience

of assessing in our pilot scheme – later this year

UKAS will publish a “Lessons Learned” review.

• At this stage there is no national standard only

“proprietary standards” – however UKAS aims

ensure the outcomes are similar and comparable

and meet the purpose of the inspection.

• Our purpose: “To assure and improve the quality of

care provided by residential care homes and other

care providers in the UK.

Accreditation of Inspection etc – some issues

• UKAS also hopes to use the requirements of the

Government Regulatory Body (“Care Quality

Commission”) to further inform the standards.

• Traditionally ISO 17020 is used for the inspection

of products, but in this pilot study we are working

with a “personal service” and UKAS had to be

sensitive to the special circumstances of providing

a service to elderly people.

Accreditation of Inspection etc – some issues

• Therefore, much work was required to

understand how to apply the standard to an

inspection of a service, with observations on

the:

- Patients

- Elderly people

- Relatives of the patients

- Interviewing persons using and providing the

service

Accreditation of Inspection etc – some issues

• This was quite a challenging process both for

the “cared for” persons and difficult for us to

observe.

• UKAS needed to ensure that the

underpinning systems and processes were

inspected in order to deliver a sustainable

service. (“It all continues to work when we are

not there”)

How accreditation works

Requirements

of accreditation

Impartiality, integrity,

independence

Competence

Appropriate resources and

facilities

Performance demonstrated to

be to required standard

Capable of sustaining the

required level of performance

The first accreditation “RDB”

• RDB – is now accredited for residential care homes

(but not yet dementia or learning difficulties persons)

• Therefore as yet there is no accreditation awarded for

specialist care – UKAS may extend scope as and

when more experience has been gained

• The RDB Scheme gives ‘star ratings’ – as this was

our first assessment, this was also a challenge of how

to assess this.

• As we move to the surveillance process, one area of

focus will be to compare outputs of the IB’s inspectors

for consistency.

The assessment team for RDB

• Assessment team – always more then one

person including witnesses.

• Complete competence criteria developed and

provided for Technical Assessors

• Qualified nurses with experience in care

homes are trained as the Technical

Assessors.

• Further steps:- possibility of a British standard

being developed by BSI for the inspection of

care homes in the coming year.

Accreditation of inspection of care homes by

independent inspection bodies cont..

• The pilot programme is now underway and is expected to be

completed by end of 2015.

• On completion of the programme and accreditation of

successful pilot applicants, UKAS will open applications to

others who wish to apply for UKAS accreditation for

inspection of adult social care providers.

• UKAS has just awarded accreditation to ISO/IEC17020:2012

to the first inspection body in the pilot scheme

• It is hoped that the UK Government Regulator for care

homes will be able to recognise adult residential care homes

which have been inspected by a UKAS accredited inspection

body and take this into account in their programme of audits.

Conclusions

• In the UK there is a growing awareness of the positive

role that accredited certification and inspection bodies

can play in helping raise quality standards in care

homes and other “patient pathways”.

• This helps adult residential care homes provide

improve high quality care for the users of their

services and assurance for Government, Regulators

and the families of those persons in residential care

homes.

Conclusions 2

• These are early days for UKAS in this area and we

have much to learn.

• Progress so far is positive and it is hoped that the

application of accreditation in this will deliver positive

benefits for the users of these services.

• Sharing of experience.

• More information: jon.murthy@ukas.com or

info@ukas.com

World Accreditation Day 2015

Thank you