Independent Healthcare Regulation Inspection Methodology March 2018
Healthcare Improvement Scotland 2018 Published March 2018 You can copy or reproduce the information in this document for use within NHSScotland and for educational purposes. You must not make a profit using information in this document. Commercial organisations must get our written permission before reproducing this document. www.healthcareimprovementscotland.org Produced by: IHC team Page: 2 of 16 Review Date:
Contents Introduction... 4 The Quality of Care Approach and the Health and Social Care Standards... 5 The Quality Framework... 5 The foundations of inspection... 7 Appendix 1: Structure of the Quality Framework... 11 Appendix 2: Frequency of independent healthcare services inspections... 12 Appendix 3: Inspection types... 13 Appendix 4: The quality grading scale and how we apply it... 14 Appendix 5: References... 16 Produced by: IHC team Page: 3 of 16 Review Date:
Introduction Healthcare Improvement Scotland is the regulator of registered independent healthcare services in Scotland. We inspect services to ensure that they comply with regulations and meet the required standards of care. Registered independent healthcare services include: independent hospitals private psychiatric hospitals independent hospices, and independent clinics. About this document This document sets out our methodology for the inspection of registered independent healthcare services. The document offers guidance on the inspection process informed by: provider self-evaluation promoting involvement of people who use services compliance with regulations, and evaluating services using the Healthcare Improvement Scotland Quality Framework domains and quality indicators. The document also sets out important principles to guide the inspection process and ensure that people who use registered independent healthcare services, including their relatives, representatives and carers, are at the heart of the process. Produced by: IHC team Page: 4 of 16 Review Date:
The Quality of Care Approach and the Health and Social Care Standards The Quality of Care Approach Our quality of care approach is how we design our inspection and review methodologies and tools and provide external assurance of the quality of healthcare provided in Scotland. There are three components: the approach itself the methodology and the principles that underpin it, that we use for all of our quality assurance work the Quality Framework outlines the quality indicators used for self-evaluation and external quality assurance, and our programmes of work the inspections and reviews that we undertake to deliver on our strategic objectives, in this case the regulation of independent healthcare services. The following principles underpin how we carry out our quality assurance function and are embedded into the design of all our programmes of work. All of our inspections and reviews are: user-focused we put people who use services at the heart of our approach transparent and mutually supportive, yet independent we promote and support a complementary approach to robust self-evaluation for improvement with independent validation, challenge and intervention as required intelligence-led and risk-based we take a proportionate approach to inspection and review which is informed by intelligence and robust self-evaluation integrated and co-ordinated we draw on the collective participation of relevant scrutiny bodies and other partners to share intelligence and minimise duplication of effort and improvement-focused we support continuous and sustained quality improvement through our quality assurance work. The principles of the quality of care approach and the Quality Framework together, provide the key point of reference to inform and guide our inspection and review activity and the development of any new programmes of work. For the quality assurance work that we lead on the Quality Framework (supplemented as required by any relevant service-specific standards, indicators or legislation) forms the basis for self-evaluation and any subsequent inspection or review. The Quality Framework The Quality Framework follows the Health Foundation 1 recommendations that Government regulators and national agencies should design their systems for oversight and regulation in a way that allows organisations to demonstrate their safety, rather than their compliance with prescriptive centrally mandated measures. It provides guidance to services, and to those externally quality assuring them, about what good quality care looks like and how this can be evaluated. It is arranged in nine broad areas of focus referred to as domains that cover all aspects of a healthcare providers work. Each domain includes quality indicators designed to help with selfevaluation and improving the quality of care provided for all users of services. These are neither exhaustive nor prescriptive. The Framework allows scope for organisations to self-evaluate and develop the narrative about the quality of the care that they provide using measures that are meaningful and important to staff locally. The nine domains in the framework can broadly be 1 http://www.health.org.uk/publication/measurement-and-monitoring-safety Produced by: IHC team Page: 5 of 16 Review Date:
grouped under three headings related to: outcomes and impact service delivery, and vision and leadership. Using a range of indicators and sources of evidence supports a holistic approach to self-evaluation and allows an organisation to tell its story. Each quality indicator is further broken down into themes and factors to consider to guide and support the process of self-evaluation. The Health and Social Care Standards In June 2017, the Scottish Government published the Health and Social Care Standards: My support, my life 2. The standards are applicable to the NHS, as well as services registered with the Care Inspectorate and Healthcare Improvement Scotland. Like the Quality Framework, the main objective of the standards is to drive improvement in the care that people receive. Services should use the standards as a guideline for how to achieve high quality care. From April 2018, the standards will be taken into account by the Care Inspectorate, Healthcare Improvement Scotland and other scrutiny bodies in relation to inspections, quality assurance activity and regulation of services. The standards are written from the point of view of the person receiving support and set out what anyone, irrespective of age or ability, should expect when using health, social care or social work services in Scotland. They seek to: provide better outcomes for everyone ensure that individuals are treated with respect and dignity, and ensure that the basic human rights we are all entitled to be upheld. The standards are underpinned by five principles: dignity and respect compassion be included responsive care, and support and wellbeing. The Quality Framework has been developed to align with the Health and Social Care Standards. Both documents should be used by service providers, users of services and by Healthcare Improvement Scotland when considering the quality of care provision. 2 http://www.newcarestandards.scot/ Produced by: IHC team Page: 6 of 16 Review Date:
The foundations of inspection Our inspectors monitor independent healthcare services regularly, using both announced and unannounced inspections. We use an open and transparent method for inspecting and reporting on our findings, using standardised processes. Our inspection process: uses our Quality Framework as the basis for self-evaluation and inspection asks independent healthcare providers to evaluate themselves and the service they provide against the Quality Framework, tell us how they think they are performing, grade themselves and identify what action they will take to make those improvements promotes the principle of involving people in our inspections makes sure we take a risk based and proportionate approach to inspection by using service risk assessment (SRA) information, previous inspection grades and other intelligence produces inspection reports with grades for services, all of which are published on our website, considers the independent healthcare providers capacity for improvement, and provides clear information about the quality of independent healthcare services. This is useful for: people who use or are choosing services, and organisations that use or buy independent healthcare services, for example local NHS boards, local authorities, corporate organisations or medical insurance companies. Why we involve people who use independent healthcare services in our inspections The Better Regulation Commission is an independent organisation which provides advice to the Government on regulation. When they consulted with people (2005), they concluded that regulation focused on paperwork rather than people, and on processes rather than outcomes. Our inspections will aim to focus mainly on outcomes for people, instead of solely on processes, for example the care people received and how that care affected their lives. The Quality Framework, as part of our Quality of Care Approach, supports us to maintain that focus on impact. During our inspections of independent healthcare services, we focus on people who use the service and promote ways that independent healthcare providers can improve people s experience of using these services. When using the term people, we mean service users, patients, clients, relatives, personal carers, personal representatives, advocates and visitors. Produced by: IHC team Page: 7 of 16 Review Date:
The four stages of inspection The independent healthcare inspection process is in four stages. Stage 1 - Inspection planning Inspection planning takes place every year. The intelligence from notifications, previous inspections (our evaluations and whether enforcement action has been taken), complaints activity, annual return, self-evaluation and the service risk assessment inform a risk based and proportionate approach to inspection. Guidance on the frequency of inspections is set out in Appendix 2. We consider the time required for an independent healthcare inspection and the number of inspection staff required, including whether it is appropriate to involve a public partner and if a clinical expert is required. We also consider the size and type of independent healthcare services we are inspecting so that an inspection approach that is proportionate to the size of the service can be applied. Stage 2 - Before the inspection During this stage we: check a provider s registration certificate and conditions of registration check the provider s annual return update the information we have about a service plan how we will involve the people who use services in our inspection review the service risk assessment score decide which type of inspection full evaluated (graded) or follow-up Consider the make up of the inspection team and if a clinical expert is required review requirements and recommendations made at previous inspections and at registration review any complaints received about the service, and develop an inspection plan. Services will be asked to submit a self-evaluation at least once every two years, depending on other information we receive, to help inform our inspection activity. Stage 3 - Inspection During the inspection we: confirm requirements and recommendations made at previous inspections and registration and resulting from complaints visit the service check the registration certificate and conditions of registration evaluate and sample evidence against the Quality Framework domains and quality indicators evaluate against the requirements of the Combined Practice Inspection documentation (for dentists) where possible, speak with people who use the services, if present during the inspection, and give feedback to the provider or service manager and, where possible, to the people who use services. See Appendix 3 for the three types of inspection. Produced by: IHC team Page: 8 of 16 Review Date:
Stage 4 - After an inspection After each inspection we: issue the inspection report in draft format and ask the service provider to make comments on factual accuracy send the final version of the inspection report to the service provider (see below for more information about our publication timescales), and request and review an improvement action plan from the service provider with responses to any requirements or areas for improvement that we make including appropriate timescales. Finalising the report and publishing grades Inspection reports will be made final: when the provider agrees with the draft report without amendment or when factual errors have been corrected following the service returning the factual accuracy error response form, or if the provider does not return the factual accuracy error response form within 5 working days of receipt of the draft report. To ensure we publish our inspection reports no later than 6 weeks following inspection, we give providers 5 working days to check their draft report for factual accuracy. The timescales for publication are detailed below: 4 weeks after inspection provider receives draft report to check for factual accuracy. 5 weeks after inspection provider returns any comments on factual accuracy, sign-off sheet and improvement action plan. 6 weeks after inspection provider receives final report. 6 weeks after inspection report and improvement action plan published on the Healthcare Improvement Scotland website. Following up areas for improvement Our approach to following up on areas for improvement will depend on the associated risk to wellbeing of those who use the service and our assessment of the independent healthcare providers capacity to improve. Our assessment of an organisation s capacity to improve will be based our overall inspection findings and closely related to our evaluation of quality indicator 9.4 Leadership of Improvement and Change. Areas for improvement will remain outstanding until we have evidence confirming the service provider has taken satisfactory action. We request a further updated improvement action plan 16 weeks after inspection if appropriate. However this updated improvement action plan may not be enough evidence. We may need to follow up with a further inspection to confirm the provider has met the requirement. In addition if the areas for improvement present a risk to the wellbeing or safety of those using the service then we will conduct follow up activity before the 16 week update of the improvement action plan. Special projects Special projects which result from ministerial requests or recurring issues arising in a number of inspections may necessitate an additional specific self-evaluation request. Following review of the Produced by: IHC team Page: 9 of 16 Review Date:
self-evaluation, a focused inspection may result. This would be informed by a risk assessment and update to the service risk assessment. See Appendix 3 for more information. Produced by: IHC team Page: 10 of 16 Review Date:
Appendix 1: Structure of the Quality Framework Produced by: IHC team Page: 11 of 16 Review Date:
Appendix 2: Frequency of independent healthcare services inspections Summary guide Service type The minimum frequency of inspection for low risk services is The minimum frequency of inspection for high risk services is Independent hospitals 1 inspection in each 36 months Independent hospices 1 inspection in each 36 months Private psychiatric hospitals 1 inspection in each 36 months Independent clinics 1 inspection in each 60 months 1 inspection in each 12 months 1 inspection in each 12 months 1 inspection in each 12 months 1 inspection in each 12 months Inspections will be proportionate and Healthcare Improvement Scotland may inspect more often than shown on this table when there are concerns about the quality of a service. Inspections can be announced or unannounced. For announced inspections, we will provide 6 weeks notification to services. Produced by: IHC team Page: 12 of 16 Review Date:
Appendix 3: Inspection types Full inspection In this type of inspection, we will assess and report on the performance of services using the Quality Framework domains and quality indicators. These are designed to give a full picture of the service. The most appropriate domains or quality indicators will be selected for individual services. We will always look at the impact on patients and ensure care is person-centred, safe and well led. On order to ensure our approach is risk based and proportionate, the domains or quality indicators that will be inspected or graded will vary between different types of service. Follow-up inspections A follow-up inspection will focus on areas for improvement made at either the fully evaluated (graded) inspection or from upheld complaints made against the service. We will evaluate how the provider has addressed these areas of improvement to improve outcomes for people using services and their families and carers. Focused inspection In response to special projects, a focused inspection may result in an inspection of a particular issue. This may involve the use of clinical experts to advise the inspection team. Produced by: IHC team Page: 13 of 16 Review Date:
Appendix 4: The quality grading scale and how we apply it Grade Level Description 4 Exceptional The service is performing exceptionally well. 3 Good The service is performing well with some areas for improvement. 2 Adequate The service is performing at a basic level. 1 Unsatisfactory The service has major weaknesses and gives cause for significant concern. Grade 4 Exceptional General criteria All aspects of the quality indicator are met or exceeded. The service is exemplary. The service s performance is a model of its type. The outcomes experienced by service users are of high quality. The exceptional performance is likely to be worth disseminating beyond the service. This grade implies these very high levels of performance are sustainable and maintained. Services graded Exceptional are rigorous in identifying their areas for improvement and implementing action plans to address them. There will be strong evidence that the service consults service users and carers regularly and appropriately about service quality and performance, and acts upon their views. Grade 3 Good General criteria All aspects of the quality indicator are met. Areas for improvement are identified but performance is basically good. The Good grade applies to performance characterised by strengths which have a significant positive impact. It implies that performance does not require significant adjustment. Identified areas for improvement will not call into question this positive impact. This grade implies that the service should try to improve further the areas of important strength and take action to address the areas for improvement. Grade 2 Adequate General criteria Most aspects of the quality indicator are met. Aspects which are not met may be subject to requirements and recommendations but don t cause significant concern. Produced by: IHC team Page: 14 of 16 Review Date:
The Adequate grade applies to performance at a basic but adequate level. This grade represents a standard where the strengths have a positive impact on the experiences of users. However, while weaknesses will not be important enough to have a substantially adverse impact, they are constraining performance. Any weaknesses that are identified are non-repeating and are addressed between inspections. This grade implies the service should address areas of weakness while building on strengths. This is likely to be reflected in requirements and recommendations for improvement in respect of legislation, relevant national standards and best practice guidance. Grade 1 - Unsatisfactory General criteria Aspects of the quality indicator are unmet in a way which gives cause for significant concern. The Unsatisfactory grade applies when there are major and or widespread weaknesses requiring immediate remedial action. There is likely to be significant concern about the experience of service users. Services graded Unsatisfactory will be likely to have requirements made against them and there will be a possibility of formal enforcement action. This scale enables members of the public to clearly determine the standard of a service, particularly those who are underperforming or excelling. It also encourages services to strive to achieve a grade of exceptional. The reduction to four grades should also help to provide consistency in grading across all services. As part of the implementation of a new grading approach, it is important that we have clear quality illustrations for each grade that are broad enough to be applied across all services. This will further ensure consistency of grading. To do this, we may have to create different sets of quality illustrations for each of the different types of services (hospices, hospitals and clinics). This will provide both services and inspectors with a reference point of what a service should be demonstrating to achieve each grade. With the range of services we inspect and the introduction of the Quality Framework from the Quality of Care Approach, it will be important to establish consistency in what we are grading. Therefore, it is important that we select key quality indicators that are applicable across all services so that they can be easily compared. In the first instance, these would be: Quality indicator 2.1 Patients and service user experience Quality indicator 5.1 Safe delivery of care, and Quality indicator 9.4 Leadership of improvement and change. This will ensure that each service is being assessed to ensure that they are well led, safe and patient centred. We will grade some but not all quality indicators assessed. Produced by: IHC team Page: 15 of 16 Review Date:
Appendix 5: References Less is more, Reducing Burdens, Improving Outcomes, London (Better Regulation Task Force, Better Regulation Commission, 2005) Principles of Good Regulation (Better Regulation Commission, 2006) Available at http://archive.cabinetoffice.gov.uk/brc/upload/assets/ www.brc.gov.uk/principlesleaflet.pdf The Evaluation of Public Service Inspection: (Boyne. G, Day. P and Walker. R, 2002) Theoretical Framework: Urban Studies 39 (7): 1197-1212 Crerar, LD (2007) The Crerar Review: The report of the independent review of regulation, audit, inspection and complaints handling of public services in Scotland, The Scottish Government Sparrow, MK (2000) The Regulatory Craft: controlling risks, solving problems and managing compliance, Brookings Institution, Washington Walshe, K (2008) Regulation and inspections of health services: IN Davis, H, Martin. S (eds) Public Service Inspection in the UK, Jessica Kingsley Publishers, London Produced by: IHC team Page: 16 of 16 Review Date: