Healthcare Improvement Scotland Quality Assurance and Regulation Plan 2025-26  

Introduction

Healthcare Improvement Scotland’s Quality Assurance and Regulation Directorate aims to make a real difference to the people of Scotland by providing confidence in the quality and safety of care provided by the NHS and independent healthcare providers, focusing on issues that we know matter most to people using services, their families and carers. We do this through independent targeted assurance work, which encourages improvement in the quality of health and social care. 

Our quality assurance and regulation activity is split into three categories: inspection, regulation, and review (including responsive inspections or reviews). We undertake these activities in a planned and proactive manner to provide public assurance on safety and quality of care and highlight areas of good practice and opportunities for learning to support ongoing improvements across the whole of Scotland. 

Our plans for each programme from April 2025 to March 2026 are outlined below. This annual Quality Assurance and Regulation Plan is continually reviewed and may be subject to further change in response to emergent external scrutiny priorities and changing resource considerations. 

An indication of the planned number of inspections and other key assurance activities are detailed below where available, however the number of planned inspections may change during the year. There are several reasons for this, including the complexity of inspections, follow-up activity that may be required in response to inspection findings, and new requests for external quality assurance in response to emergent concerns which may require the rapid redeployment of resource and reprioritisation of existing work programmes. 

NHS inspections

Our NHS Inspections currently focus on four areas – hospital inspections, adult mental health inpatient service inspections, maternity inspections within the acute setting and the inspection of healthcare within justice. 

Over the coming year we will continue our safe delivery of care methodology for inspections of NHS hospitals. Our mental health services and maternity inspections within the acute setting will also be undertaken using our safe delivery of care methodology. We will also continue to work in collaboration with partner agencies to inspect healthcare services within prisons and police custody. 

All our NHS inspections will take account of and respond to the pressures being experienced across NHS Scotland that may impact on the safe delivery of care, reporting this impact on patient care through inspection reports. 

Programme – NHS Acute Hospital inspections 

Aim

To provide assurance of the safe delivery of care in NHS hospitals through targeted inspection activity that is reflective of and responsive to the evolving context of service delivery. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Inspection activity

Our single and multi-site inspections will continue to be risk-based and proportionate. It is intended 10 hospital inspections will be carried out within NHS board areas between April 2025 and March 2026. 

Inspection reports and associated improvement action plans will be published on our website. Locations of inspections are not available as these are unannounced. 

Programme – NHS Acute Adult Mental Health Inspections 

Aim

To contribute to the safety and wellbeing of patients and service users within mental health services through targeted inspection activity that is reflective of and responsive to the evolving context of service delivery. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Inspection activity

There are 10 inspections planned for 2025-26. A report will be published for each inspection. 

Programme – NHS Acute Maternity Inspections 

Aim

To provide assurance of the safe delivery of perinatal services in NHS hospitals through targeted inspection activity that is reflective of and responsive to the evolving context of service delivery.

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Inspection activity

There are eight inspections planned for 2025-26. A report will be published for each inspection. 

Programme –  Joint inspection of prisoner healthcare 

Aim

Healthcare Improvement Scotland works with His Majesty’s Inspectorate of Prisons for Scotland (HMIPS) to provide expertise to the inspection of healthcare in prisons in Scotland. 

Scrutiny body/bodies involved

His Majesty’s Inspectorate of Prisons for Scotland (lead agency) and Healthcare Improvement Scotland 

Inspection activity

There are four inspections planned for 2025-26, A report will be published for each inspection. Follow-up activity (eg inspections) will also take place where required. 

Programme –  Joint inspection of police custody centres 

Aim

Healthcare Improvement Scotland works with His Majesty’s Inspectorate of Constabulary for Scotland (HMICS) to provide expertise to the inspection of healthcare in police custody centres in Scotland. 

Scrutiny body/bodies involved

His Majesty’s Inspectorate of Constabulary in Scotland (lead agency) and Healthcare Improvement Scotland 

Inspection activity

There are three inspections planned for 2025-26. A report will be published for each inspection. Follow-up activity (eg inspections) will also take place where required. 

Multi-agency Inspections

Our strategic multi-agency inspection programmes focus on three areas – joint Inspection of adult support and protection, joint inspection of adult services and joint inspection of services for children and young people. 

Joint adult support and protection inspections were led by the Care Inspectorate in collaboration with Healthcare Improvement Scotland and His Majesty’s Inspectorate of Constabulary in Scotland as part of the Scottish Government’s Adult Support and Protection Improvement Plan 2019-2022. The plan built on the joint inspections of adult support and protection that were undertaken in 2017-18. We have now completed phase one of our programme of joint inspections of adult support and protection. We jointly inspected 25 partnerships and published our findings.  

Phase 2 of the adult support and protection programme has been designed with a clear improvement focus. It comprises four complementary workstreams including: inspection activity; the development of a quality improvement framework which will be available for use by the sector to support multi-agency self-evaluation; progress review activity with partnerships found to have significant areas for improvement during phase 1 and focused work related to early intervention and trauma informed practice. Phase 2 of this programme is due to complete at the end of July 2025. 

The joint strategic inspections of services for adults, and for children and young people, will continue with the same respective methodologies as during 2024-2025. In 2025-2026 joint inspections of adult services will focus on adults living with mental illness and their unpaid carers. Joint inspection of services for children and young people will change its focus from children at risk of harm to children looked after at home, from autumn 2025. 

Programmes will be kept under regular review for any impacts of the reduced financial envelope and any new commissions on our ability to deliver planned work with the resources available to HIS and our partner agencies. 

Programme –  Joint inspection of adult support and protection (phase 2) 

Aim

This work seeks assurance that adults at risk of harm in Scotland are supported and protected by existing national and local adult support and protection arrangements and supports adult protection partnerships to improve. 

Scrutiny body/bodies involved

Care Inspectorate (lead agency), Healthcare Improvement Scotland and His Majesty’s Inspectorate of Constabulary in Scotland 

Inspection activity

The fourth and final phase 2 workstream will conclude in summer 2025.  This workstream comprises supported self-evaluation activity with 11 volunteer adult protection partnerships, focusing on support, early intervention, prevention, and trauma informed practice in adult support and protection. 

Programme –  Joint inspection of adult services (integration and outcomes) 

Aim

Healthcare Improvement Scotland has a statutory responsibility to undertake joint inspections of services for adults with the Care Inspectorate. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland and Care Inspectorate 

Inspection activity

The intention is to complete up to two joint inspections of health and social care partnerships during 2025-26. These joint inspections will focus on the effectiveness of Partnership working in creating seamless services that deliver good health and wellbeing outcomes for people and their unpaid carers, through the lens of different service user groups. 

Programme –  Joint inspection of services for children and young people 

Aim

The inspection programme takes account of the experiences and outcomes of children and young people in need of care and protection by looking at the services provided for them by community planning partnerships in each of Scotland’s 32 local authorities. 

Scrutiny body/bodies involved

Care Inspectorate (lead agency), Healthcare Improvement Scotland, His Majesty’s Inspectorate of Constabulary in Scotland, and Education Scotland. 

Inspection activity

Development work to develop and implement a joint methodology for inspections with a new focus on children looked after at home with commencement of first of 6 inspections planned for autumn 2025. 

Our regulation programmes focus on delivery of all elements of our regulatory responsibilities for both independent healthcare (IHC) and Ionising Radiation (Medical Exposure) Regulations (IRMER). This includes proactive inspections, responding to notifications of incidents and enforcement activity for both programmes of work, and registration of IHC services and investigations of complaints about these registered services. 

As well as delivering these programmes we are working through a period of review and improvement for both IHC and IRMER. Currently both are part of the external review of our regulatory activity. In relation to our IRMER inspection activity we are developing a new graded approach to the inspection of all facilities where ionising radiation is used for medical exposures.   

Programme –  Ionising Radiation (Medical Exposure) Regulations (IRMER) 

Aim

Through inspections and the notifications process, the aim of this work is to provide public assurance of the safe use of ionising radiation for medical exposure. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Inspection activity

An inspection plan is in place to carry out at least 10 inspections. Routine inspections are announced. In addition, we will respond to all notifications (approximately 130 per year) and take forward recommendations from the Integrated Regulatory Review Service mission. 

Programme – Independent Healthcare (IHC) 

Aim

Healthcare Improvement Scotland is the regulator of registered independent healthcare services in Scotland. 

Our regulatory functions include: 

• registering IHC services 
• proactive inspections of registered services 
• investigating complaints about registered IHC services 
• responding to notifications from IHC registered services 
• taking enforcement action of registered IHC services where necessary, and 
• continued development work to support the regulation of IHC. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Inspection activity

The planned number of inspections of IHC services for 2025-26 is 129 to take account of ongoing internal deep dive review of systems and process for the regulation of independent healthcare. Planned inspection numbers will be reviewed once we are aware of the number of new registrations from independent medical agencies and may increase during 2025-26. 

The number of planned inspections may change throughout the year for a range of reasons including: 

• high priority reactive activity that requires resource to be diverted from planned inspections 
• cancelled registration of a service 
• follow-up inspections in response to initial inspection findings. 

Working collaboratively to review and respond to concerns about the quality and safety of services

Programme –  Responding to Concerns 

Aim

Healthcare Improvement Scotland has a duty to respond to patient safety/quality of care concerns raised about NHS services by NHS Scotland employees or referred to us by another organisation. All concerns made to us are subject to a level of assessment to ensure an appropriate response. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Inspection activity

Ongoing process of assessment and investigation of concerns raised, and communication with those raising concerns. 

Internal systems and processes for responding to concerns will be further improved, through the implementation of recommendations from an external review which took place during 2024. 

Programme –  Sharing Health and Care Intelligence Network 

Aim

The Sharing Health and Care Intelligence Network (SHCIN) is a mechanism that enables seven national organisations with a scrutiny, improvement, or training role at system/service level in Scotland, and nine professional regulators, to share, consider, and respond to intelligence and emerging issues that may indicate risks about health and social care systems across Scotland. 

Scrutiny body/bodies involved

• Audit Scotland 
• Care Inspectorate 
• General Chiropractic Council 
• General Dental Council 
• General Medical Council 
• General Optical Council 
• General Osteopathic Council 
• General Pharmaceutical Council 
• Healthcare Improvement Scotland 
• Health & Care Professions Council 
• Mental Welfare Commission for Scotland 
• NHS Education for Scotland 
• Nursing and Midwifery Council 
• Public Health Scotland 
• Scottish Public Services Ombudsman 
• Scottish Social Services Council 

Key activity

The SHCIN focuses on prioritisation of emerging issues in the health and care system which supports a more agile and responsive approach, taking early action on new risks as individual network members or as a collaborative across the SHCIN. 

The group will meet on a quarterly basis during 2025-26, with the option to convene a review panel meeting should an emerging concern arise out with scheduled meetings. 

Reviewing and learning from adverse events, children and young people’s deaths, and death certification

Programme –  Learning from adverse events 

Aim

Support a consistent national approach to identification, review, reporting and learning from adverse events based upon national and international good practice. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Key activity

The Adverse Events toolkit will be launched in 2025 following the publication of the revised framework for Learning from Adverse Events in NHS Scotland. 

The National Standardisation programme for adverse events reporting will continue alongside a new data management plan to allow for improved monitoring and targeted assurance interventions. Data and intelligence regarding Significant Adverse Events Reviews and how NHS boards are adhering to the revised national framework will be monitored on an ongoing basis, and any significant concerns will be raised with relevant NHS boards 

There will be further development of the Adverse Events on-line community of practice along with the development of learning systems including a redesigned learning summary. All NHS boards will have a designated area of the main hub site to share learning from adverse events. 

Programme –  National Hub for reviewing and learning from the deaths of children and young people 

Aim

Healthcare Improvement Scotland, in collaboration with the Care Inspectorate, co-host the National Hub for Reviewing and Learning from the Deaths of Children and Young People and aim to ensure the death of every child and young person is reviewed to an agreed minimum standard. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland and Care Inspectorate 

Key activity

The National Hub will continue to process data on the deaths of children and young people, from National Records Scotland, on a weekly basis. 

The National Hub will receive and quality assure relevant data from NHS boards and local authorities. 

The work of the National Hub in 2025/26 will be shaped by the findings and recommendations in the first Data Overview Report, published in March 2024.  Data will be used to help to improve understanding of emerging contributory factors in child deaths and look at ways of sharing learning. A further data report will be published in May 2025. 

Improvements will be made to our systems for monitoring and responding to signals in the data, through a new data management plan. 

A new data set has been developed and shared for consultation for sudden unexpected deaths in infants and children, (SUDIC). This data set, once agreed, will be implemented as part of the core data received into the National Hub. 

Programme –  Death Certification Review Service 

Aim

The Death Certification Review Service (DCRS) provides independent scrutiny of deaths in Scotland not reported to the Procurator Fiscal with the aim of improving: 

• the quality and accuracy of Medical Certificates of Cause of Death (MCCDs) 
• public health information about causes of death in Scotland 
• clinical governance issues identified during the death certification review process 

The service is also responsible for authorising repatriation to Scotland of persons who have died abroad. 

Scrutiny body/bodies involved

Healthcare Improvement Scotland 

Key activity

DCRS will: 

• Review approximately 12% of Medical Certificates of Cause of Death (MCCD). 
• Provide advice around death certification via the DCRS enquiry line. 
• Review all applications for repatriation to Scotland and where appropriate approve disposal. 

Responsive Reviews

There are no responsive reviews planned for 2025/26. This Quality Assurance and Regulation Plan will be updated if a need for a responsive review is identified