Regulation in the NHS and other high risk industries

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Presentation transcript:

Regulation in the NHS and other high risk industries Professional Standards Authority Conference, 9-10 March 2017 Eirini Oikonomou, University of Oxford

Agenda Overview Background/ Aims Mapping the regulatory landscape Reflexions Summary

Background Healthcare Regulation first appeared in 1421. NHS Trusts accountable to several organisations. Berwick review (2013): ‘The system is bewildering in its complexity and prone to both overlaps of remit and gaps between different agencies’. NHS providers, Survey (2015): ‘The regulatory process is inconsistent and burdensome’.

Literature review Limited empirical evidence on the impact of regulation on health care providers. Mostly opinion/ descriptive papers/ policy documents.

Aims Map regulatory landscape for patient safety in healthcare. Illustrate the benefits and burden of regulation from providers’ level. Contrast regulation in healthcare with other high risk sectors.

Mapping the regulatory landscape Definition/ Inclusion criteria. Classification and mapping. Regulatory activity recording and activity overlap.

Definition Regulation: Process that aims to shape, motivate, monitor and modify the practices and technologies within organizations so as to achieve some desired state of affairs (Hutter, 2001).

Inclusion criteria Score: 4/4 Consider the improvement of patient safety as a part of their organisational responsibilities. Undertake some form of monitoring or oversight of safety related to standards or performance. Engage in formal attempts to influence other organisations' safety performance. Derive some form of legitimacy or external authority for their work (on safety). Score: 4/4

Classification System Oversight Regulators Influencers

System Oversight Department of Health NHS England Public Health England

Regulators Services regulators Professionals regulators Products regulators

Services Regulators Care Quality Commission (CQC) NHS Improvement United Kingdom Accreditation Service (UKAS) Human Fertilisation and Embryology Authority etc.

Professionals Regulators General Medical Council (GMC) General Dental Council (GDC) General Chiropractic Council (GCC) General Optical Council (GOC) etc.

Products Regulators Human Tissue Authority (HTA) NHS Blood and Transplant Medicines and Healthcare Products Regulatory Agency (MHRA) Etc.

Influencers Information and standards Professional Peer Review and Quality Improvement Advisory Groups Royal Colleges Professional Associations National Commissioning Groups Consultancy Other

Activity Recording Reviewed: Websites Annual reviews Strategic plans Meeting minutes Recorded patient-safety related activities. Created list of responsibilities.

Regulatory Activities Set Standards Quality improvement Register health care services/providers/professionals Collect and analyse data and share data and information with other organisations Accreditation/Licensing/Revalidation Advice and support the public Policy provider Advice and support health care providers/ other regulators or DH Monitor/ rate care services/professionals Representation/ Advocacy/Promotion Investigate Professional development/ Education and Training Inspect Impose sanctions/fines/penalties Research

Regulatory Activities- Example CQC  Set Standards  Register health care services/providers/professionals  Accreditation/Licensing/Revalidation  Policy provider  Monitor/ rate care services/professionals  Investigate  Inspect  Impose sanctions/fines/penalties Quality improvement  Collect and analyse data and share data and information with other organisations  Advice and support the public  Advice and support health care providers/ other regulators or DH Representation/ Advocacy/Promotion Professional development/ Education and Training Research

Patterns of regulatory activity: Services Standards Register Accredit Policy Monitor Investigate Inspect Sanctions QI Data Public support Advisor Advocacy Training Research CQC  NHS Impr UKAS HFEA HSE IBMS EA NHSLA Coroners Police

Impact of regulation on Trust Clinical Pathology Accreditation UK (CPA) Joint Accreditation Committee QARC JobCentrePlus NHSLA Clinical Negligence Scheme General Dental Council ISO Human Tissue Authority HFEA IQIPS Environment Agency SEL Cardiac Stroke Network Connecting for Health CQC Cancer Peer Review OFSTED HTA MHRA Regulatory Reform (Fire Safety) London Health Programme

Regulator's perspective CQC Memorandum of Understanding Agreement (MoU): 26 CQC Joint Working Protocol (JWP): 6 CQC Information Sharing Agreement (ISA): 19 Total: 51

Reflections Accessing information from 400+ websites. Keeping up with changes in landscape. Distinguishing patient safety regulation activities. Classifying regulatory actors who do not consider themselves as ‘regulator’. Developing an effective data collection template.

Summary Listed and classified regulatory agencies/actors in healthcare. Monitored patient safety related functions. Illustrated activity patterns/ areas of overlap. Highly complex area with various actors involved. Further insights into the impact of regulation in healthcare from case studies.

eirini-oikonomou@psy.ox.ac.uk