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External Quality Regulation

External Quality Regulation

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The External Quality Regulation project was established within the Health and Care Transformation Programme to support the Department of Health and Social Care who will ensure that there is a consistent, independent and systematic approach to the inspection of all health and care services delivered or commissioned by Manx Care.

The External Quality Regulation Team are contactable by email at externalqualityregulation@gov.im

Last updated: 23 January 2023

Background

Recommendation 3 of Sir Jonathan Michael’s Independent Review of the Isle of Man Health and Social Care System called for health and social care services provided directly or indirectly by Manx Care to be inspected regularly by independent, external quality regulators, with a report to the Manx Care Board and to the Department of Health and Social Care (DHSC). It was also recommended that the inspections are determined against agreed defined standards that provide assurance yet require the enforcement of the recommendations and support a systematic approach to a continuous improvement.

Following the recommendation, the Care Quality Commission (CQC) in England was identified as being able to assist recommendation 3 and conduct initial baseline inspections of the majority of services in adult social care (ASC), primary medical services (PMS) - including GPs, dental care, minor injuries and out of hours - and the hospitals. DHSC commissioned CQC to carry out these baseline inspections, a service level agreement (SLA) was signed in July 2021 to conduct this work.

About the Care Quality Commission (CQC)

The Care Quality Commission register, inspect and regulate health and social care services in England. Their expertise in regulation and inspection to support the recommendation when approached, made them the best placed organisation to undertake a baseline inspection of services provided and/or commissioned by Manx Care and furthermore support the development of an ongoing approach to independent external quality inspections.

Timeline of inspection activity

The work on the Isle of Man is being undertaken in three phases. There was a period of engagement undertaken by DHSC with the services and key stakeholders on the framework up until the inspections began. CQC have undertaken pilots of the ASC and dental inspection methodology on the Isle of Man at the end of February 2022. The GP and core service pilots have also taken place.

Details of the three phases can be found below. 

Phase 1 - Validation and scoping exercise (July to November 2021) 

This phase involved workshops to map the end to end methodology for delivering inspections across the Island and focused primarily on service-wide and location-level baseline assessments.

Phase 2: Discovery and self-assessment (December 2021 to March 2022) 

The assessment framework has been adapted in co-production with services to help them understand what intelligence is available, how they can hear about people’s experiences of care, and understand the quality of care being delivered by services, from services.   

Engagement work commenced with the services in connection with the Provider Information Requests (PIR). 

The DHSC in conjunction with CQC will consult on the framework by: 

  • learning what data is available
  • managing provider information requests
  • delivering webinars
  • undertaking pilot inspections

Phase 3: The inspection phase (April 2022 to March 2023)

This is the inspection phase where CQC has undertaken a baseline assessment of the services commissioned and provided directly and indirectly by Manx Care on behalf of DHSC.

Timing for Inspections per sector (correct at 23 January 2023) are:

  • The Adult Social Care inspection schedule ran from 25 April to 12 August 2022
    • 9 x Adult Care Home
    • 27 x LD Adult Care Home
    • 7 x Other Social Care Service

  • The Dental inspection schedule ran from 4 July to 15 July and 29 November 2022
    • 13 x Dental Practices

  • The General Practice inspection schedule ran from 26 July to 8 November 2022
    • 13 x GP Practices

  • The Mental Health Sector inspection ran during the week commencing 1 August. The remaining section of the inspection will be held week commencing 30 January 2023

  • The Acute (Hospital based services) and Community Services sector inspection schedule began on the 3rd October. The Well-led inspection was undertaken week commencing 24 October 2022

The Well-led inspection was also undertaken by CQC of the Acute and Community Services, which is an assessment of; the leadership and governance at board and executive team level, the overall organisational vision and strategy, organisation-wide governance, management, improvement; and organisational culture and levels of engagement.

  • The Hospice Care Sector inspection was carried out during week commencing 31 October 2022

DHSC have been working across Manx Care to co-develop the assessment frameworks and establish the necessary guidance, so that all services being inspected knew what to expect and feel supported and confident in the process, as well as understanding its purpose.

This information has been shared with services directly via regular newsletter bulletins and the DHSC microsite. If you are a service provider or member of staff and want to receive the bulletin or please email externalqualityregulation@gov.im including your name and email address to be added to the mailing list. We would like to encourage all staff working in health and social care across the Isle of Man to sign up, as the information isn’t just aimed at managers. Alternatively, should you wish to opt-out of receiving the bulletin please contact the EQR team on the above email address.

Services being inspected

All services provided directly and indirectly by Manx Care are to be inspected. Although CQC are able to inspect the majority of these services, there are a small number not ordinarily regulated by CQC in England and therefore out of their scope. These include day services for learning disability and older people, community ophthalmic, community pharmacy and some children and family services. Investigation work is underway with other regulators to determine whether they are able to inspect those services that currently sit outside of the scope of CQC.

Private services that do not receive Manx Care funding will not be inspected by the CQC during these initial baseline inspections. However, if they are registered under Regulation of Care Act 2013 (ROCA) they will be inspected as usual by the DHSC Registration and Inspection Team and further discussions are already progressing to include the inspection of all independent services in the future.

What the inspectors assess

DHSC have asked CQC to help ensure that services provide people with safe, effective, compassionate and high-quality care, taking into consideration the specific requirements of the Island.

Their observations and analysis consider all aspects of services including:

  • Patient safety
  • Effective governance processes
  • The level of compassion and dignity afforded to people using services
  • The outcomes following people’s care, treatment and support

Inspectors gather the views of the people who use services, the employees who work in the services and will observe care, individual care pathways, records, documentation, policies and the places in which people are cared for.

CQC also inspect employee records in regards to: Mandatory Training, Disclosure Barring Service (DBS) checks, Professional Certificates, evidence of Employment History, References obtained (Yes or No), Indemnity Insurance expiry dates if applicable, photographic Identification, professional registration reference no & date (where applicable), Start Date, Last Appraisal / Performance review date, Qualification Type and certificate date.

All of this information helps to create the baseline assessment of the overall level of care being delivered.

View details of the inspection process.

More about the EQR inspections

Why health and care services should be inspected regularly by independent external quality regulators

Sir Jonathan Michael’s recommendations aim to achieve a high-quality, integrated, personcentred and sustainable health and care system on the Island. Implementing recommendation 3 contributes to this through the delivery of a consistent, independent and systematic approach to the inspection of services provided directly and indirectly by Manx Care. Regulation is a fundamental part of any modern health and care system that seeks to ensure high quality services. It serves to protect the public from harm, provide confidence in the quality of services and support a culture of continuous improvement. It can also serve to educate, acknowledge good performance, ensure good practice is shared and available to everyone and assist government in making new legislative changes.

How DHSC are taking a collaborative approach

All executives in the DHSC and Manx Care have been involved in the project to date, as have Primary Medical Services, acute and social care colleagues. Thanks to the input, most aspects of the health and care provision have been taken into consideration when planning the methodology and continued engagement with the staff and services across Manx Care. This is crucial to the quality of the inspections being delivered.

Work that has taken place following Sir Jonathan Michael's recommendation

Following the recommendation, the Care Quality Commission (CQC) in England was identified as being able to assist and conduct initial baseline inspections of the majority of services in adult social care (ASC), primary medical services (PMS) (including GPs, dental care, minor injuries and out of hours) and the hospitals. DHSC commissioned CQC to carry out these baseline inspections, a service level agreement (SLA) was signed in July 2021 to conduct this work and Phase 1, the validation phase was concluded in November 2021. During Phase 1, CQC staff and specialist advisors held a series of workshops and on-Island meetings with management across Manx Care, DHSC and several of Manx Care’s contractors.

This has aided organisations involved to better understand what and when engagement is required and how CQC will apply its current inspection approach to the nuances and challenges of the provision of Health and Care on the Island.

The initial scoping exercise has taken place, mapping out a bespoke end-to-end process that would best fit services on the Island. The result of that work established the current intention 2 to send each provider and location a report containing a baseline assessment, which does not contain any ratings. CQC has not been given enforcement powers as part of this work.

Phase 3 began with inspections of the ASC services commencing at the end of April and concluding in August, with CQC inspectors visiting the island regularly to review services according to the program.

Question and Answer sessions for the GP and dental services were held during May and June to allow practices the ability to communicate directly with CQC and DHSC regarding their pending inspections.

Inspections of Dental and GP services commenced at the start of July and will be concluded by the end of October.

The Hospital pilot inspection was conducted in the Urgent & Emergency Care department. Following on from this, CQC’s standard assessment framework has been shared with each of the Care Groups to be disseminated for feedback.

Co-producing the framework is integral to creating a bespoke approach which reflects the uniqueness of the Isle of Man. Therefore, several engagement sessions, including a Q&A opportunity have been held over the last few weeks with the different Care Groups.

CQC's enforcement powers on the Isle of Man

CQC are a regulator of health and social care in England and therefore do not have enforcement powers over services on the Isle of Man, their role is to consult and advise. Any enforcement action taken as a result of inspection findings would be the responsibility of the DHSC.

Notice before an inspection takes place

Prior to an inspection taking place, DHSC, Manx Care and CQC will have had sufficient communications with the service in order to prepare the PIR documents for the inspection to take place. CQC will not turn up unannounced at any service.

On the day of the inspection

Management and staff should work as they normally would when inspectors are present. This is to help the inspectors get a true picture of the care being delivered to people. This can help support services to know where to focus their attention if there are recommendations to improve the quality of care for local people. It will also demonstrate areas of good practice that CQC can share with others to learn from. Staff should explain clearly to patients and service users who the inspectors are.

Inadequate findings

In the event of failures being identified in the CQC report, timescales to remedy such situations have been agreed upon between Manx Care and the DHSC and a subsequent re-inspection may be commissioned. Appropriate sanctions are available to the DHSC in the event of a failure by Manx Care to improve poor services. All reports highlighting issues will be the responsibility of Manx Care to create improvement plans to deliver the required changes, working alongside the providers to follow up with remediation and provide assurance to the DHSC. Should CQC become concerned about people’s immediate safety during a visit, there is an escalation process that will be followed, to report such findings and for the DHSC to investigate the matter further as per the Manx Care Act 2021.

Inspection considering the circumstances of services as an island health and care system

Whilst the assessment frameworks and inspection principles used will be broadly based on those used in England, the frameworks used on the island will be nuanced to accommodate the specific requirements of the Isle of Man. Inspectors will follow the 5 key lines of enquiry - Safe, Caring, Responsive, Effective and Wellle - as agreed in the assessment frameworks. Each area will then be inspected with its own bespoke co-produced framework, where local area specialists across ASC, PMS, and the hospital from the Isle of Man have also contributed their feedback in workshops and engagement sessions.

Rating

The baseline reviews across services will ensure that DHSC and Manx Care have a picture of the level of safety and quality of care across services. These first inspections will not be rated but will have recommendations for improvement. This will enable services to develop action plans and mitigate any risks whilst they are implementing these actions, prior to any future inspection work. Any recommendations for improvement arising from an inspection will be the responsibility of Manx Care, with support from the DHSC. Any enforcement required will be managed by the DHSC. CQC do not regulate these services and therefore do not have enforcement power.

Publishing the reports

Inspection reports will be produced by CQC at provider level for acute care/secondary care and location level for other services. Reports will go through a factual accuracy process with services and internal CQC quality assessment, then they will be shared with the DHSC and the Manx Care Board. Reports will cover CQC’s findings against the five key questions detailed in the assessment frameworks. It is proposed at the baseline level these are used to identify and celebrate good practice and any areas for improvement.

The first batch of CQC inspection reports are being published during October 2022 and contain all 43 of the Adult Social Care reports and all 13 of the Dental Practice reports too.

The second batch of CQC inspection reports are the General Practice reports published during January and the following batch will be the Acute (Hospital based services) and Community Services and Isle of Man Hospice Care published in due course.

Benefits of the inspections

This baseline assessment gives services on the island an independent assessment of the level of care they are providing in order to support any necessary improvement work. This also gives the healthcare system as a whole on the Isle of Man, the opportunity to share good practice and identify areas where services need a systemic response in order to prioritise improvement.

DHSC can then also use these baseline assessments to work with Manx Care, agreeing priorities that will support the Isle of Man government to deliver their Island Plan 2022, in which health and care transformation is their number one priority. This will help them to shape what regulation on the Isle of Man might look like in future.

If you have any concerns or complaints for CQC's attention

Individual complaints from people using services should be directed via the Manx Care complaints process as normal. 

As part of the process the CQC inspection team will be in contact with people using services and their families, we would encourage you to please use this opportunity to share your views of the service.

If you work in a service and want to raise a concern

If you work in a service and have concerns about the quality of care being delivered, you can provide this information directly to DHSC who can escalate as appropriate. You can email externalqualityregulation@gov.im to do this, and any information will be treated confidentially.

If you need more information

Should you have any queries or concerns, please contact externalqualityregulation@gov.im

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