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{{org_field_name}}

Registration Number: {{org_field_registration_no}}

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Regulated Activities Compliance Policy

1. Purpose

The purpose of this policy is to ensure that {{org_field_name}} operates in full compliance with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This policy establishes clear guidelines on how we manage regulated activities efficiently, ensuring that our care services meet Care Quality Commission (CQC) requirements and maintain high standards of safety, quality, and effectiveness.

This policy also explains how {{org_field_name}} will evidence compliance under CQC’s current assessment approach, including the Single Assessment Framework (SAF). The SAF retains the five key questions (Safe, Effective, Caring, Responsive and Well-led) and is structured around Quality Statements and CQC’s evidence categories. We will maintain “always-ready” regulatory evidence (including policies, audits, training compliance, supervision/appraisals, complaints and incident learning, governance meeting minutes, and service user outcomes/feedback) so we can demonstrate compliance at any time.

2. Scope

This policy applies to:

• All staff, including care workers, registered managers, and senior leadership.
• Service users and their families, ensuring they receive legally compliant care.
• Regulatory bodies, including CQC, ensuring our operations meet statutory requirements.
• Healthcare professionals and external agencies, involved in delivering care.

It covers:

• Legal and regulatory compliance for regulated activities.
• Registration and CQC requirements.
• Care delivery and service user safety.
• Risk management and governance.
• Staff training, monitoring, and auditing processes.

3. Legal and Regulatory Framework

This policy aligns with, and must be read alongside, the following legislation and regulatory requirements (as amended from time to time):

• Health and Social Care Act 2008 and associated regulations and CQC guidance.
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Fundamental Standards), including but not limited to Regulations 9–20 and associated CQC guidance.
• Care Quality Commission (Registration) Regulations 2009 (as amended), including requirements relating to registration, changes to registration, and statutory notifications.
• CQC assessment methodology, including the Single Assessment Framework (the 5 key questions and Quality Statements) and associated evidence expectations.
• Regulation 20: Duty of Candour and CQC guidance on meeting the duty (openness and transparency and the required actions when things go wrong).
• Mental Capacity Act 2005 (consent, capacity assessments and best-interest decision-making).
• Equality Act 2010 (non-discrimination and reasonable adjustments).
• Data Protection Act 2018 / UK GDPR (lawful processing, privacy, security and confidentiality).
• Care Act 2014 (adult safeguarding duties, prevention, and multi-agency working).
• Safeguarding Vulnerable Groups Act 2006 (DBS and barred list considerations).
• Learning disability and autism training requirements, including the Oliver McGowan Code of Practice (standards for statutory learning disability and autism training for CQC-registered providers and their staff).

4. Registration and CQC Compliance

{{org_field_name}} ensures compliance through:

• CQC Registration:
  • The organisation is registered with CQC for all applicable regulated activities.
  • Regular updates are submitted for any changes in service provision or management.
  • Changes to the Registered Manager, nominated individual (where applicable), Statement of Purpose, locations, and regulated activities are notified to CQC in line with registration requirements.
• CQC Inspections and Compliance:
  • We align to CQC’s current assessment approach, including the Single Assessment Framework, and we maintain evidence against the 5 key questions (Safe, Effective, Caring, Responsive and Well-led) and the relevant Quality Statements.
  • Evidence management: We maintain an evidence file (digital and/or hard copy) that is kept up to date and includes audits, incident and complaint learning, training compliance, supervision records, service user feedback, outcomes measures, and governance minutes/action plans.
  • Provider submissions (including PIR or other CQC requests): We complete and submit provider information accurately and on time, and we ensure the information submitted is consistent with our internal governance evidence and audit outcomes.
  • Statutory notifications: We submit CQC notifications within required timescales and keep an internal log of all notifiable events, actions taken, learning identified, and improvement measures implemented.
  • Action plans are developed following inspections to address any recommendations or areas of improvement.

 

5. Fundamental Standards (Regulations 9–20): How we comply

{{org_field_name}} complies with the Fundamental Standards by ensuring the following minimum arrangements are in place, followed in practice, and evidenced:

• Regulation 9 – Person-centred care: Care plans are co-produced, outcomes-focused, reviewed at agreed intervals, and updated after changes in need, risk, or preference.
• Regulation 10 – Dignity and respect: Staff follow dignity standards (privacy, choice, respectful communication, cultural needs, and personal presentation). Dignity is monitored through spot checks, feedback and supervision.
• Regulation 11 – Need for consent: Consent is obtained and recorded. Where capacity is in doubt, Mental Capacity Act assessments are completed and best-interest decisions are documented, including family/advocacy involvement where appropriate.
• Regulation 12 – Safe care and treatment: Risks are assessed and controlled (including falls, pressure risk, nutrition/hydration, medicines, infection prevention and control, lone working, and environmental risks). Medicines support is delivered in line with assessed need, staff competence, MAR recording standards, and clear escalation for errors/omissions.
  
  
• Regulation 13 – Safeguarding: Staff recognise and report signs of abuse/neglect immediately and follow safeguarding procedures, including referral to the local authority where required. Safeguarding concerns are logged, investigated proportionately, and outcomes/learning are recorded and used to improve practice.
• Regulation 14 – Meeting nutritional and hydration needs: Where the service supports food and drink, care plans specify dietary needs and risks (including choking risk) and staff record and escalate concerns promptly.
• Regulation 15 – Premises and equipment: Where the provider supplies equipment, it is suitable, maintained and checked; faults are reported promptly and actions are recorded.
• Regulation 16 – Receiving and acting on complaints: Complaints are welcomed, responded to within published timescales, investigated proportionately, and learning/improvements are recorded and shared.
• Regulation 17 – Good governance: We operate an effective governance system including audits, KPI monitoring, action tracking, management oversight and learning loops (incidents, complaints, safeguarding and feedback).
• Regulation 18 – Staffing: Staffing levels and skill mix are planned to meet needs; recruitment and deployment support safe continuity; training and competence are monitored and actioned.
• Regulation 19 – Fit and proper persons employed: Recruitment includes robust checks (DBS/ID, references, employment history, right to work and role suitability) and ongoing suitability monitoring.
• Regulation 20 – Duty of candour: We are open and transparent when things go wrong, meet the notification, apology and written follow-up requirements, and keep a duty of candour log with learning and follow-up actions.
• Learning disability and autism training: We ensure staff receive learning disability and autism training appropriate to role, aligned to the Oliver McGowan Code of Practice, and we retain evidence of completion, refreshers and impact on practice.

6. Care Delivery and Service User Safety

To ensure safe and effective care:

• Comprehensive care planning is conducted for every service user, considering their needs and preferences.
• Person-centred care is promoted, ensuring dignity, independence, and choice.
• Medication management procedures comply with Medicines Act 1968 and NICE guidelines.
• Safeguarding policies are in place to protect service users from abuse and neglect.
• Regular service reviews ensure that all aspects of care are being delivered safely and effectively.

7. Risk Management and Governance

We ensure safe regulated activities through:

• Risk assessments conducted for all service users and operational activities.
• Incident reporting and investigation procedures that promote transparency and continuous learning.
• Health and safety measures ensuring a safe working environment for staff and service users.
• Data protection and confidentiality protocols that comply with the UK General Data Protection Regulation (UK GDPR), the Data Protection Act 2018, as amended by the Data (Use and Access) Act 2025, and other applicable data protection requirements.

Data Protection Complaints

{{org_field_name}} will maintain an accessible process for receiving and handling complaints concerning the processing of personal information, in accordance with the Data Protection Act 2018, as amended by the Data (Use and Access) Act 2025.

Where a person considers that there has been an infringement of data protection legislation in connection with their personal information, {{org_field_name}} will:

• Facilitate the making of a data protection complaint by providing an accessible means for the person to submit their complaint, including an appropriate electronic method.
• Acknowledge receipt of the complaint within 30 days beginning on the date the complaint is received.
• Take appropriate steps to respond to the complaint without undue delay.
• Make appropriate enquiries into the subject matter of the complaint.
• Keep the complainant informed of the progress of the complaint where appropriate.
• Inform the complainant of the outcome of the complaint without undue delay.
• Maintain appropriate records of the complaint, investigation, response and any actions arising from it.

Data protection complaints will be managed separately from, or clearly identified within, the organisation’s general complaints process so that the statutory requirements applying specifically to data protection complaints are met.

Governance Calendar

Audits and governance reviews are scheduled monthly, quarterly or annually as appropriate, with clear owners, completion dates and escalation routes for overdue actions.

Regulatory Notifications Governance

We maintain a central register of notifiable events, including safeguarding outcomes, serious incidents and deaths where applicable, and record the decision-making process regarding whether a CQC notification is required under the Care Quality Commission (Registration) Regulations 2009.

Quality Monitoring Aligned to CQC

Audit tools, KPIs and management reviews are mapped to the five key questions and relevant Quality Statements so that regulatory evidence is current and readily available.

8. Statutory notifications to CQC (Care Quality Commission (Registration) Regulations 2009)

{{org_field_name}} will comply with statutory notification requirements by:

• Maintaining a “notifiable events” log and a recorded decision for whether a CQC notification is required.
• Submitting notifications accurately, completely and within required timescales.
• Ensuring staff know internal escalation routes so notifiable events are reported immediately to the Registered Manager/on-call manager.
• Auditing notification compliance (sampling incidents/records to confirm notifications were made and learning/actions were completed).

9. Staff Training and Competency

All staff undergo:

• Mandatory induction training, including safeguarding, infection control, and regulated activities compliance.
• Learning disability and autism training that meets the standards in the Oliver McGowan Code of Practice, appropriate to each role, with recorded completion, refresher arrangements and evaluation of impact on practice.
• Ongoing CPD (Continuous Professional Development) to maintain knowledge of legislation changes.
• Regular competency assessments to ensure all staff meet required care standards.
• Supervision and appraisal sessions to review performance and regulatory adherence.

10. Monitoring, Auditing, and Continuous Improvement

To uphold compliance:

• A planned programme of audits is completed (monthly/quarterly/annually depending on topic and risk), and findings are translated into time-bound action plans that are tracked to completion and reviewed for effectiveness.
• Service user feedback is gathered to refine and improve care delivery.
• Annual policy reviews align with changes in legislation and best practices.
• CQC feedback and inspections are used to drive improvements.

 

11. Policy Review and Updates

This policy is reviewed annually or sooner if:

CQC inspections recommend revisions.

Regulatory updates require changes.

Internal audits identify areas needing improvement.

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Responsible Person: {{org_field_registered_manager_first_name}} {{org_field_registered_manager_last_name}}
Reviewed on: {{last_update_date}}
Next Review Date: {{next_review_date}}
Copyright © {{current_year}} – {{org_field_name}}. All rights reserved.