The NHS position regarding accreditation of laboratories

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NHS Provider Organisations England

Dear Chief Executive Officer / Medical Director

Re: NHS England, NHS Improvement and Care Quality Commission’s position on Diagnostic Accreditation Schemes

We write to outline NHS England (NHS E), NHS Improvement (NHSI) and the Care Quality Commission’s (CQC) position on Accreditation Schemes for Diagnostic Services provided to NHS Patients in Provider Trust Organisations (Appendix 1: United Kingdom Accreditation schemes).

Diagnostic services underpin more than 80% of clinical pathways and account for a considerable proportion of NHS expenditure. Diagnostics is fundamental to patient care, therefore it is increasingly important that we promote high quality diagnostic provision and are assured that patients are accessing services that meet government recognised accreditation standards.

Therefore, NHS England, NHS Improvement and the CQC are committed to, and strongly endorse, participation in accreditation schemes for diagnostic services (Appendix 2 and 3). Participants in these schemes undergo a rigorous independent review of their services, at regular intervals in time, and have systems in place for ongoing and continuous quality management and service improvement.

CQC will consider the accreditation status of diagnostic services as part of their assessment of NHS Trusts. It will use a Trust’s participation in these accreditation schemes, and their performance in these schemes, as evidence of the quality of the diagnostic services and of the Trust’s commitment to quality improvement. This evidence will inform CQC’s judgements; both of core services that include diagnostic services and of the quality of leadership overall - as assessed as part of the Trust-wide well-led review that is now a key part of CQCs monitoring, inspection and regulation of NHS Trusts.

Further information on CQC’s use of accreditation can be found in ‘How we monitor, inspect and regulate NHS trusts’ (Appendix 3). Any further questions can be directed to Claire Land, Acute Policy Manager ([e-mail]).

Yours sincerely

Prof Stephen Powis Medical Director NHS England

Prof Ted Baker Chief Inspector of Hospitals CQC

Dr. Kathy McLean Executive Medical Director and Chief Operating Officer NHS Improvement

Appendix 1: United Kingdom Accreditation Schemes (UKAS)

UKAS is the UK’s National Accreditation Body, responsible for determining, in the public interest, the technical competence and integrity of organisations such as those offering diagnostic testing, calibration and certification services.

S c h e m e s:

Laboratory Accreditation (ISO/IEC 17025):

This standard is used to confirm or recognise the competence, impartiality and consistent operation of laboratories other than Medical Laboratories. It applies to all laboratories performing tests and/or calibrations that are not medical in nature. This standard is for Laboratories where testing and/or calibration is part of inspection or product certification, or where there is a general requirement for the competence of testing for Physical Measurement and Calibration to be consistent and accurate. It covers the following fields:

 Calibration

 Chemical

 Construction and Construction Products

 Electrical

 Environmental

 Fire and Textiles

 Forensics

 Geotechnical

 Renewable Energy

Medical Laboratory Accreditation (ISO 15189):

This Scheme covers laboratories that are involved in testing Patient samples for diagnostic, prognostic and treatment purposes, referred from medical disciplines. It covers laboratories in the following fields:

 Clinical Biochemistry – Toxicology – Endocrinology

 Haematology - Blood Transfusion

 Microbiology - Virology - Parasitology – Serology – Mycology

 Histopathology – Cytology – Mortuaries

 Immunology

 Genetics and Genomics

 Andrology

 Histocompatibility & Immunogenetics

Diagnostic Imaging Services Accreditation Scheme (ISAS)

This scheme covers all imaging services used for diagnostic purposes. The United Kingdom Accreditation Service (UKAS) has been licensed by The Royal College of Radiologists and the College of Radiographers to manage to deliver the ISAS. The Scheme covers all Imaging Services including

 Radiology

 Ultrasonography

Physiological Services Accreditation (IQIPS)

This Scheme covers all Physiological Services used in the provision of care for patients including:

 Audiology

 Cardiac Physiology

 Gastro-Intestinal Physiology

 Neurophysiology

 Ophthalmic and Vision Science

 Respiratory and Sleep Physiology

 Urodynamics

 Vascular Science.

Appendix 2: NHS England Endorsement 2016

NHS England’s position on accreditation schemes for diagnostic services

The mandate from Government to NHS England sets out objectives to improve the nation’s health and createthehighestqualityhealthcareservice. Asignificantnumberoforganisationsarealready contributing to these objectives by providing high quality diagnostic services that are accredited under government-recognised schemes.

NHS England remains committed to, and strongly endorses, participation in accreditation schemes for imaging (ISAS), physiology (IQIPS), endoscopy (JAG) and Pathology including Genetics and Genomics (CPA/UKAS ISO 15189) services.

We fully support a commissioning system focus on the prioritisation of accredited diagnostic services. We are confident that with continued resolute focus, accreditation will become the baseline standard for diagnostic services across the NHS in England.

NHS England will continue to promote inclusion in future relevant guidance and policy, and will work in partnership with health system partners to ensure this is a focal point for review and inspection.

[helvella Administrator]

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