What is the purpose of accreditation? 

What are the benefits and opportunities?

What is the scope of accreditation?

What are the stages involved in developing an accreditation scheme?

What support is available?

How is accreditation funded?

How to operate an accreditation scheme? 

What does the assessment process involve?

What is the purpose of accreditation?

a. What is accreditation and what does it seek to achieve?

Accreditation is a process of validation in which a clinical service is evaluated. It is a formal, third party recognition of competence to perform specific tasks. In order for a new accreditation scheme to operate, it is desirable to meet the British Standards Institution (BSI) PAS 1616 standard for provision of clinical services.

b. What is the difference between accreditation and certification?

Accreditation is the formal recognition by an ‘accreditation authority’ of the organisational competence of an assessment body, to carry out a specific service in accordance to the standards and technical regulations. UKAS is the UK’s National Accreditation Body (www.ukas.com).

Certification is the procedure by which a third party gives written assurance that a system, process or person conforms to specified requirements.   This may be offered by a ‘certification body’ for example a royal college or other institution.

c. Does Accreditation provide ‘Value for money’?

Value for money refers to getting the best health outcomes for a given cost. This can be achieved by improving the quality of care, or reducing costs (while maintaining standards of care), or both. The variation in all health outcome measures and associated costs indicates there is considerable value to extract from the system.  If we do not achieve best value for money, then patients are not getting the best care possible within the resources allocated to their treatment. Consequently, there is less money to invest in services because it is being wasted on less effective care. Accrediting services can support effective use of resources and provide re-assurance of high quality care.

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What are the benefits and opportunities?

a. What are the key benefits of accreditation for a clinical specialty/service?

Accreditation is a measure of the quality, safety and patient centredness of a clinical service. Knowing a clinical service is accredited then reassures patients and commissioners that the service has achieved a certain standard of care for its patients. It also provides a framework that can support alignment and measurement of other quality initiatives intended to improve patient care.


• Stimulates continuous improvement in processes and patient outcomes

• Protects the public by reducing risk

• Increases patient confidence in services

• Improves the management and efficiency of services

• Accelerates adoption of innovation and transformation

• Improves education and development of the workforce

b. How does it align with regulation or other types of inspections?

Accreditation will be based on the Publicly Available Specification (PAS)1616, a British Standards Institute specification for clinical services.  PAS1616 will be fully aligned with the Key Lines Of Enquiry used by the Care Quality Commission (CQC). It is anticipated that current accreditation schemes will eventually migrate to PAS1616 and in the interim, the standards they use will be mapped to PAS1616 so that patients and commissioners can see how well the scheme matches PAS1616.

c. How will this initiative reduce the burden on healthcare providers?

The PAS 1616 is generic and suitable for many clinical services.  Each specialty will have underpinning criteria that is specific to them.  Up until recently, every accreditation scheme assessed similar things but had a unique set of standards to base the assessment on.  This meant a provider had to respond differently to prepare for every accreditation process its services were involved in.  Having a single assessment framework creates a common language and a common approach to the improvement and accreditation of services.  This simplifies things for providers and enables them to better share best practice between clinical services.

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What is the scope of accreditation?

a. What is the definition of a clinical service?

A group of health and, when relevant, social care staff and facilities and the processes that link them; both with each other and with other components of the wider healthcare system. The clinical service so defined must be meaningful to both clinicians and patients. It might:

• Be a single health care facility such as a ward, a clinical pathology laboratory or a primary care centre

• Comprise a group of staff and facilities that work together, as a ‘virtual team’ to provide care to a common group of patients; such as people who have had a stroke or those being assessed and managed for memory problems. The staff and facilities that make up this ‘virtual team’ might either be co-located within a particular setting, such as a general hospital, or be distributed across a number of settings

• Provide care to patients at a particular time-point and level of care, such as anaesthetic practice within a general hospital, or provide care to patients over time and across the boundaries between health and social care and between primary and secondary care.

The latter might be defined as a care pathway, although accreditation standards might include those that relate to broader organisational processes, such as training, recruitment and finance management, in clinical service accreditation the focus of these organisational standards will be on the impact that these processes have on the quality of clinical and social care.

b. Can any clinical specialty/service be accredited? 

Part of the Clinical Service Accreditation Alliance’s vision is to discourage the creation of small schemes because this increases burden and complexity. The current aim is to eventually have about 40 schemes covering most of healthcare. Work stream 3 of the CSAA created a map of potential areas for clinical services accreditation schemes. The primary purpose of this work stream was to test the feasibility of mapping healthcare to a limited number of schemes but more importantly to act as a starting point for future discussions csaa.uk/clinical-accreditation-map/

The prioritisation of new schemes has been based on a number of factors:

• The existence of current quality improvement initiatives in that area of healthcare (the existence of these reduces the urgency of developing accreditation)

• The difficulty in configuring a scheme in that area (while we should not be put off by developing accreditation schemes in areas whose configuration makes this difficult, testing pathway accreditation will be challenging enough without added complications)

• The drive from an area of healthcare to develop accreditation (accreditation works best when driven by the profession. Buy in from all relevant stakeholders helps to push accreditation and builds momentum for its development and adoption)

• The need for quality improvement in that area of healthcare

The four factors above will contribute to the order in which new schemes are developed. Further to creating the map as the main output, guidance to support discussions that emerging schemes have with their stakeholders has been drawn up and has been fed into work stream 6 Developing accreditation schemes for clinical services.

c. Is accreditation flexible enough to accommodate both small and large services?

Yes. Accreditation schemes are expected to be flexible enough to asses both large and small services.  Ideally schemes should be UK wide and apply to all types of providers for that particular service, such as private providers. For some schemes there may be minimum entry requirements to ensure that the service is operating at the expected level.

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What are the stages involved in developing an accreditation scheme?

a. How is it best to approach the development of a new scheme?

HQIP, as part of the original CSAA programme of work has developed guidance that can support the work needed to develop a new scheme.  The guidance is aimed at any body or group of stakeholders who wish to develop an accreditation scheme in their clinical specialty. The guidance is relevant to all those developing accreditation schemes whether they are in an advanced stage of development or not. For those at an early stage it will ensure that all essentials steps are taken from the outset. For those who have already made progress it will act as a checklist to ensure that they have considered all important factors www.csaa.uk/development-good-practice-guide

b. How much work is involved and how long does it take?

There are some very important steps that need to be worked through before a new scheme can be implemented.  This is a large commitment and should not be rushed. It is essential to get all stakeholders on board from the start if the scheme is to be successful. The scoping and preparation stages that involve the review of the PAS 1616 and underpinning criteria takes up to 12 months.  The HQIP guidance: ‘Preparing for development of a clinical service accreditation scheme: A good practice guide’ provides a step-by-step plan for all those intending to develop a new scheme.

c. Who would need to be involved?

The best way to secure commitment and an adequate level of resources to develop the accreditation scheme is through broad support from all relevant stakeholders. It is essential to identify all stakeholders that may support and/or benefit from the scheme. No accreditation scheme can be set up in a vacuum. It is important to take account of the past history of the relationships between various groups. It is essential to create a collaborative ethos involving all stakeholders:

• Patient engagement: take account of key relationships, identifying current and potential future partnerships. Ad hoc meetings should be set up with patient group leads to explain what is involved and seek their views on the potential to improve standards for patients through an accreditation scheme

• Professional engagement: identify clinical leadership or a champion early in the process; this is critical to early engagement with services. Refer to pages 9 and 10 of the HQIP guidance ‘Preparing for development of a clinical service accreditation scheme: A good practice guide’

d. How are patients involved in accreditation?

Patients have been actively involved in the development of all projects hosted by HQIP. Importantly the development of PAS 1616 involved a wide stakeholder group, including patient representatives. In terms of schemes themselves it is expected that lay representatives are involved in the development, governance and assessment of clinical services. It is common practice for lay assessors to work alongside professionals from the clinical specialty to assess services; this ensures that the patient is at the heart of the process

e.What standards should be used and how do I obtain them? 

The BSI developed the Publicly Available Specification – PAS 1616:2016 Healthcare – Provision of clinical services. It is for use by any clinical service that provides treatment and/or care to clinical service users.

It specifies requirements for the provision of clinical services and covers the following aspects:

• Clinical service planning and clinical service definition

• Leadership, strategy and management

• Person-centered treatment and/or care

• Risk and safety

• Clinical effectiveness

• Clinical service users with complex needs

• Staffing a clinical service• Improvement, innovation and transformation

• Educating the future workforce

It does not cover service-specific requirements for an individual clinical service. If you currently subscribe to British Standards Online (BSOL) and have the Sciences and Healthcare module (GBM 05), then this document has already been added to your collection and you can access PAS1616 free of charge. Please go to the BSOL home page and enter your log in details as usual.

HQIP has been able to secure a limited number of free copies of PAS1616 for NHS providers who are interested in and committed to self-assessment of and improvement of their clinical service. If you would like to be considered for one of these free copies, please complete the short questionnaire available here.

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What support is available? 

a. Is support available to develop an accreditation scheme and from whom?

Yes. The work of the Clinical Service Accreditation Alliance is now hosted by the Healthcare Quality Improvement Partnership (HQIP). HQIP can support teams wishing to establish schemes.

b. Is there more information about the support that HQIP offers?

For further advice and information please go to the HQIP website contact tel: 020 7997 7370 or email accreditation@hqip.org.uk.

c. What are the costs?

HQIP are keen to support  the development of accreditation. Therefore proposals and costs will be developed depending on specific needs and considering individual circumstances (e.g. not-for-profit/ charitable status)

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How is accreditation funded?

There are two types of costs to consider: development and operational costs.  The development costs include the early groundwork to prepare for the scheme including developing the underpinning service-specific criteria.  The delivery of an accreditation scheme is usually run on a cost recovery basis. Individual services usually pay an annual subscription fee, which includes periodic on-site assessment and access to resources.

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What is involved in operating an accreditation scheme? 

a. Is it expected that a clinical specialty will operate its own scheme?

No, not necessarily. Administering an accreditation scheme is not a small undertaking and there should be careful thought and analysis before a decision is made. The options are to operate the scheme or to outsource to an accredited provider, or one who can demonstrate competence as a provider. It is expected that all providers of schemes will either be accredited or work towards accreditation standards for scheme providers so that they are recognised by the Care Quality Commission (see also CSAA guidance ‘Certification Body requirements: Requirements and guidance for the accreditation of Certification Bodies providing clinical service certification schemes’)

HQIP and UKAS have developed specific guidance to support the achievement of ISO/IEC 17065 that can be used for the accreditation of Provider Bodies (also known as Certification Bodies) that operate clinical service assurance schemes. It sets out requirements and relevant guidance to assist Provider Bodies and UKAS, where the Provider Body requires accreditation. Please see page 15 of the  CSAA guidance ‘Preparing for development of a clinical service accreditation scheme: A good practice guide’ 

b. What level of clinical involvement should there be? 

Professional engagement and clinical leadership throughout the process is critical to the success of the scheme. Refer to the HQIP guidance – Preparing for development of a clinical service accreditation scheme: A good practice guide https://csaa.uk/development-good-practice-guide/

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What is typically involved in an accreditation assessment?

What is typically involved in an assessment? Is there a pathway?

The pathway involves two stages:

• Stage one: quality improvement

• Stage two: quality assurance
Stage one involves improving the clinical service to work towards the standards.  This is usually supported by an IT web tool, online and other resources, and training.

During Stage two the service submits an application that includes a self-assessment showing it has achieved all the standards with supporting documentation . Qualified assessors review the uploaded documentation to determine if all accreditation requirements have been met. In some cases the examination of documentation may be accompanied by telephone interviews or site visits by assessors. Once a service is accredited it is expected to demonstrate compliance annually through an annual review.   In most schemes a revisit takes place every 3-5 years.

b. Who are typically the assessors?

Assessment teams are made of clinical, managerial and lay representatives that represent the specialty.  The assessment teams are usually made up of an experienced medical consultant and lead nurse from the specialty with support from an experienced manager and lay assessor.

c. Care across organisational boundaries is not always possible, so why should my service be prevented from achieving accreditation if I have no control over other providers?   

If organisations do not work together, patient care will be compromised and opportunities to achieve value for money will be lost. So while it might seem unfair to an organisation for its service not to be accredited when it has no control over another organisation responsible for part of the service, it is also unfortunate for patients (and sometimes the taxpayer) when organisations are not able to work together. Patient focused accreditation will act as a powerful lever on organisations to work together and create transactional processes that support doing the right thing for patients.

d. What is the outcome for services which do not achieve accreditation?  

Services should only be advised to apply for accreditation once they are confident that they meet or almost meet the accreditation standards. If a service is assessed as not meeting the standards, a number of outcomes are possible:
• A service close to meeting the standards may be given a time frame to resolve issues and, if it complies, accreditation will follow.

• A service determined to be some distance from meeting the standards may be provided with detail of the areas in which it needs to improve and be asked to reapply for accreditation once the changes have been made.

• If there are concerns about patient safety and if these are not dealt with immediately, the service will be referred to the relevant regulator.

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