Health and Social Care Act 2008 Registration and Compliance Monitoring Maggie Hannelly Compliance Manager Bedfordshire 6 December 2010

Our registration programme People can expect services to meet essential standards of quality, protect their safety and respect their dignity and rights. Registration Single system of registration Single set of standards Strengthened and extended enforcement powers Adult social care NHS Independent healthcare

Registration timeline NHS Trusts April 2010 Oct 2010 April 2011 April 2012 Adult social care and independent healthcare providers (CSA) Primary dental care (dental practices) and independent ambulance services Primary medical services (GP practices and out of hours)

Registration under Health and Social Care Act 2008 Widen scope of registration Registration relates to the provision of ‘Regulated Activities’ Registered at provider level rather than location Location is a condition of registration Registration no longer includes ‘categories’ of care or need It is against the law to carry out a regulated activity without registration

Application made Application assessed Judgement made Judgement published Regulatory judgement Regulatory response Judgement on risk Information capture Information analysis Ongoing monitoring of compliance Registration application Registration Cycle

Application made Application assessed Judgement made Judgement published Registered Registered with conditions Registration refused in part Registration refused Registration application Registration Cycle

Transitional Registration Conditions Restrictive Conditions  Registered manager  Bed numbers (where appropriate)  Prohibit the provision of nursing care Compliance Conditions  Registered manager  Significant none compliance  Overall major concerns  Provider or location level It is an offence to fail to comply with conditions of registration and may lead to prosecution

8 Listen to the people who use services – they know what is really happening What Next

Compliance Monitoring Following registration with CQC a provider of services must maintain compliance with essential standards of quality and safety These aim to ensure that people who use services are protected and receive the care, treatment and support they need Compliance teams will monitor a service providers compliance with regulatory requirements and the essential standards Responsive and planned reviews are a key compliance monitoring methods

Regulatory judgement Regulatory response Judgement on risk Information capture Information analysis Ongoing monitoring of compliance Compliance Monitoring Continuous process Information Capture ‘Quality Risk Profile’ Information, analysis and risk Regulatory response Judgement and reporting

11 How we capture information We will hold a Quality and Risk Profile on each provider summarising all relevant information. The Quality and Risk Profile will enable us to assess where risks lie and prompt front line regulatory activity, such as inspection. As new information arrives, it will be added to the profile and assessors and inspectors will be alerted and will take action proportionate to the risk.

Information capture People who use services, families and carers New information can come from a variety of sources: Other regulatory bodies and Information Centre Other bodies eg. Ombudsman, commissioners Providers Staff and other professionals CQC Assessors and Inspectors

Provider Compliance Assessment (PCA) Must submit evidence to CQC when requested within given timeframe Can use the PCA self assessment tool Focuses on outcomes for the 16 essential standards These are the standards most directly related to quality and safety Set out in part 4 of Health and Social Care Act 2008 (Regulated Activities) Regulations There is a separate PCA for each regulation and associated outcome Each PCA relates to one location

Provider Compliance Assessment (PCA) Use as a routine, internal quality assurance tool Enables you to monitor progress and develop action plans Use alongside ‘Essential Standards and Judgement Framework’ Enables you to respond swiftly to CQC request for information Format and guidance available on CQC internet

CQC’s guidance about compliance documents

16 Essential Standards OutcomeRegulationDescription 117Respecting and involving people who use services 218Consent to care and treatment 49Care and welfare of people who use services 514Meeting nutritional needs 624Cooperating with other providers 711Safeguarding people who use services from abuse 812Cleanliness and infection control 913Management of medicines 1015Safety and suitability of premises 1116Safety, availability and suitability of equipment 1221Requirements related to workers 1322Staffing 1423Supporting workers 1610Assessing and monitoring the quality of service provision 1719Complaints 2120Records

Reviews of compliance Responsive A responsive review of compliance: is triggered when specific information, or a gap in information raises concern about compliance is not a full check of all 16 core quality and safety outcomes is targeted to the area(s) of concern May include a site visit All findings will be published Planned A planned review of compliance: is a scheduled check that looks across all regulated activities (at a location) to assess compliance with all 16 core quality and safety outcomes Will take place at intervals of three months to no less frequent than two years Will be proportionate, with additional activities focused on gaps on information May include a site visit All findings will be published

Monitoring Compliance Visits Carried out under Section 62 Health and Social Care Act 2008 CQC specific powers of entry and inspection Visiting the service Focused and targeted Generally unannounced Visits are one of a range of assessment tools Primary purpose to listen and observe Findings ‘triangulated’ with other information held about the service

Monitoring Compliance Determine Regulatory Response Actions to maintain compliance with essential standards Report to CQC re the action needed and time frame Inform us when you have taken the action detailed Improvement Action Actions to achieve compliance with essential standards Report to CQC re the action needed and time frame Inform us when you have taken the action detailed Dependent on risk factors Range of options – civil and criminal Compliance Action Enforcement Action

Monitoring Compliance Reporting Utilised where issue is too serious to wait for report to be produced Send provider ‘compliance action letter Highlighting area of concern Report to CQC re action needed and time frame Inform us when action has been taken Urgent Compliance Action Public facing document - Published on CQC website Produced after each responsive or planned review of compliance Includes analysis / evaluation of all information not just a visit (if conducted) Include standards assessed only Compliance Report

Formal Regulatory Action Civil enforcement action Warning Notice Conditions  Variation / Removal / Imposition  Urgent variation / removal / imposition Suspension  Extend period of suspension  Urgent suspension Cancellation  Cancel registration  Urgent cancellation Criminal law and options Warning Notice Fixed Penalty Notice Simple Caution Prosecution Improvement Action Compliance Action

Offences : Fixed Penalties OffenceFixed Penalties Failure to comply with regulations about quality and safety (see regulation 27 of activities regulations Provider £4,000 Manager £2,000 Carrying out a regulated activity without being registered£4,000 Failure to comply with conditions of registrationProvider £4,000 Manager £2,000 Carrying out a regulated activity while registration is suspended£4,000 Managing a regulated activity while registration is cancelled or suspended £2,000 Obstructing entry and inspection£300 Failure to provide documents or information£300 Failure to provide an explanation of any relevant matter£300

Offences and fines: Prosecution OffenceFine Failure to comply with regulations about quality and safety (see regulation 27 of activities regulations £50,000 Carrying out a regulated activity without being registered£50,000 Failure to comply with conditions of registration£50,000 Offences relating to suspension or cancellation£50,000 False description of concerns£5,000 False statement in applications£2,500 Obstructing entry and inspection£2,500 Failure to provide documents or information Failure to provide an explanation of any related matter £2,500

More information Go to our website at  Guidance for professionals  Online communities of providers and commissioners Ring or send enquiries to our National Contact Centre at or