Care Quality Commission Essential Quality & Safety Outcomes Assurance Process

Transcription

1 Process and Guidance Document for Executive Leads, Outcome Co-ordinators and Responsible Managers v3.3 Ratified by: BISE Ratified: February 2012 Review: February 2014 Care Quality Commission Essential Quality & Safety Outcomes Assurance Process Process and Guidance Document for Executive Leads, Outcome Coordinators and Responsible Managers ID Number Author s name Patricia Duncan Author s job title Assiociate Dir. Clinical Governance & Risk Division Corporate Department Clinical Governance & Risk Management Version number Version 3.3 Ratifying Committee Integrated Standards Executive Ratified date February 2012 Review date February 2014 Upload date June 2013 Name of manager responsible for review Patricia Duncan Job title of manager responsible for review Associate Dir. Clinical Governance & Risk address for this manager Patricia.Duncan@whht.nhs.uk Referenced (Yes/No) Yes Key words (to aid searching) Safety, Quality, Assurance User Group All Staff Equality Impact Assessment Completed Yes The Trust is committed to promoting an environment that values diversity. All staff are responsible for ensuring that all patients and their carers are treated equally and fairly and not discriminated against on the grounds of race, sex, disability, religion, age, sexual orientation or any other unjustifiable reason in the application of this policy, and recognising the need to work in partnership with and seek guidance from other agencies and services to ensure that special needs are met.

2 Contents 1. Introduction 3 2. CQC Outcomes 3 3. Definitions 4 4. Assuring Outcomes 4 5. Accountability Structure for Delivering Assurance 5 6. Registration of Activity, Service and Location The Quality and Risk Profile The Trusts Assurance Process CQC Unannounced Inspections 14 Appendix A The PCA Process for Outcome Coordinators 17 Appendix B Provider Compliance Assessment (PCA) Template 18 Appendix C Registration of Activity, Service and Location 19 Appendix D Assurance and Escalation Structure 34 Appendix E Outcome Leads and Responsible Committees 35 Appendix F Student Review of Placement following non compliance 37 Appendix G Outcomes where assurance is not required 38 Change History Version Date Author Reason Ratification Required 1 Feb 2010 Patricia Duncan Document provides guidance for staff on Yes the Trust assurance processes 2 July 2011 Nick Past Expiry Yes Egginton 3 February 2012 Nick Egginton Inclusion of PCA assurance template Yes 3.1 April 2012 Maxine McVey Inclusion of guidance / review of student No placement if an inspected area is identified as non compliant with a CQC Outcome Page 2 of 38

3 3.2 Feb 2013 NE Format change of PCA No 3.3 May 2013 NE Reasons why the Trust is not measuring No compliance with outcomes 3, 15, 18, 19 and Introduction The Care Quality Commission (CQC) is the regulator of health and social care services in the United Kingdom. Its function is to ensure the implementation of the Health and Social Care Act, 2008 which introduced a regulatory framework within which all providers of NHS health and social care services must be registered with the Care Quality Commission. The application to register required provider organisations to declare whether or not they are meeting standards of service quality and safety set out in the registration requirements. (Reference: CQC Website Essential Standards of Quality and Safety): Registration replaced the Core Standards Assessment (CSA) component of the Annual Health Check where organisations were required to submit a Declaration of Compliance with Core Standards for Better Health. The last Core Standards Declaration for all NHS organisations was submitted in December The system of registration is based on a system of continuous assessment whereby Trusts are required to continually monitor compliance with standards of Quality and Safety set out in the registration regulations. This places greater emphasis on outcomes for patients and this will be a core component of compliance with registration requirements. The outcomes set out in the Essential Standards of Quality and Safety have been developed in consultation with clinicians and patients and cover areas of real importance to patients, such as safety and quality of care and also how accessible services are to patients. 2. The CQC Outcomes The standards of safety and quality are arranged under the following section headings: Involvement and Information Outcome 1: Respecting and Involving People who use services Outcome 2: Consent to care and treatment Outcome 3: Fees Personalised Care, Treatment and Support Outcome 4: Care and Welfare of people who use services Outcome 5: Meeting Nutritional Needs Outcome 6: Co-operating with other providers Safeguarding and Safety Outcome 7: Safeguarding people who use services from abuse Outcome 8: Cleanliness and Infection Control Outcome 9: Medicines Management Page 3 of 38

4 Outcome 10: Safety and suitability of premises Outcome 11: Safety, availability and suitability of equipment. Suitability of Staffing Outcome 12: Requirements relating to workers Outcome 13: Staffing Outcome 14: Supporting workers Quality and Management Outcome 15: Statement of purpose Outcome 16: Assessing and monitoring the quality of service provision Outcome 17: Complaints Outcome 18: Notification of death of a person who uses services Outcome 19: Notification of death or unauthorised absence of a person who is detained or liable to be detained under the Mental Health Act 1983 Outcome 20: Notification of other incidents Outcome 21: Records 3. Definitions Term Quality and Risk Profile (QRP) Essential standards of quality and safety Judgement framework Review of compliance report Provider compliance Assessment (PCA) Outcome evidence Unannounced Visit Description A tool that gathers all the information the CQC knows about the Trust to enable them to assess risk and prompt regulatory activity. Guidance to help the Trust comply with the regulations. It is based on the outcomes that the CQC expect people using a service will experience when the Trust is compliant with essential standards. Provides a framework for CQC inspectors when making a judgement about compliance, as well as a guide for providers about the judgements the CQC will make. Summarises the findings of a review of compliance including any improvement actions or enforcement activity for publication. Tool for Trusts to evidence their compliance with essential standards. The evidence used to demonstrate the outcomes described in the Guidance about compliance: Essential standards of quality and safety To gather additional information, an inspector may visit a site to carry out observations, interviews and discussions. Page 4 of 38

5 4. Assuring Outcomes Assurance is a term familiar to us all we want assurance about any goods or services we buy and similarly patients will want to be assured that the healthcare they experience at WHHT is of high quality and is safe. The Trust s Board has ultimate responsibility for the standard of healthcare delivered by the Trust and it will therefore, on behalf of patients, require assurance that services meet the essential standards of quality and safety set out in the registration guidance. Those who purchase services on behalf of patients, the Clinical Commissioning Groups will also require assurances. This is achieved partly through the monitoring of the Quality element of the Acute Services Contract with Commissioners but will now also be obtained from the new system of registration. This guidance document explains the Trust s approach to gaining assurance about the safety and quality of services and sets out the responsibilities all staff in contributing to and monitoring the Trust s compliance against the Essential Standards for Quality and Safety. It explains the structure for assurance, the responsibilities of key committees and specific responsibilities of staff. 5. Accountability Structure for Delivering Assurance Responsibilities for delivering the outcomes required rests with all members of the organisation, whether clinician or manager, administrator or porter. This will only be possible by maintaining a patient centred approach at all times. However assurance functions will require specific areas of responsibility to be assigned to individuals. The below guidance clarifies the responsibilities of: The Nominated Individual Executive Leads Outcome coordinators/leads Other roles that contribute to the overall outcome The Nominated Individual (NI) is the Chief Executive. The NI must give notice to the CQC as the person who is responsible for supervising the management of the regulated activity by the Trust. The NI has a responsibility for reviewing status reports and in particular to ensure review of areas for which there are concerns about compliance. If an Executive Lead has any concerns with outcome compliance, they need to be reported to the Chief Executive for approval to report non-compliance to the Care Quality Commission. It is the Nominated Individual s responsibility to ensure the conditions for registration are maintained. The Executive Lead (EL) would be for example the director of workforce, director of strategy and infrastructure or director of nursing, they have a responsibility, on behalf of their Board colleagues, for: Ensuring arrangements are in place to deliver outcome requirements that fall within their executive portfolio and that these arrangements are understood across corporate and service functions. Page 5 of 38

6 Ensuring that individuals with specific responsibilities in relation to compliance, such as Outcome coordinators/leads, have those responsibilities reflected in their job descriptions and within their work plans. Obtaining assurance that outcomes that require action within their portfolio remit are effectively managed to achieve implementation. Ensuring that a thorough assessment of compliance has been completed and that appropriate arrangements are in place to manage the risks, implement action plans and monitor progress of such action plans and risk mitigating activity. Provide executive colleagues with assurance of compliance. Ensure that escalating risks in relation to compliance are communicated to an appropriate forum, and that their implications are addressed Escalate any areas of concern that would represent a barrier to compliance to the Delivery Service Group. Approving the Trusts Provider Compliance Assessments (PCAs) The Outcome Co-ordinator (OC) or lead is responsible for: Developing and maintaining an understanding of the requirements of registration in relation to the outcome standard for which they have responsibility. Maintaining active engagement with colleagues to understand and work through the implications for compliance. It is to be expected that the Outcome Co-ordinator will act as the key liaison point with external/internal network groups in relation to the outcome for which they have co-ordinating responsibility. The Outcome Coordinator is expected to read and understand the following guidance (as a minimum) from the CQC: - Guidance about Quality and Safety Outcomes that relate to their area of responsibility (this may cut across a number of outcome areas this information is in the CQC document: Essential Standards of Quality and Safety. - The Judgement Framework - Quality and Risk Profile this is summary of the Trusts risk status compiled by the CQC based on external assurances / reports. - The Quick Guide to Compliance Monitoring Ensure that evidence to support compliance assurance is easily accessible, preferably electronically, and is organised methodically and catalogued for ease of access. This will ensure that the Trust is always prepared for an unannounced visit by external agencies, and in particular the Care Quality Commission. Page 6 of 38

7 Ensuring, via liaison with the relevant Chair, that the Terms of Reference for the Responsible Committees are updated to reflect the responsibility of such committees for overseeing the work required to assure and maintain compliance with the required outcome, and that these responsible committees review the appropriate PCA and challenge assurances where appropriate. Completion of compliance reports know as PCAs (example report in Appendix B) for the outcome(s) for which they have responsibility, in line with the reporting cycle. Ensure compliance with reporting timescales. Ensuring action plans are in place and on target to address any areas of noncompliance or insufficient assurance. Where there are in-year lapses with compliance, they must be reported to the EL who will be expected to escalate such lapses to the Patient Safety Quality and Risk Committee. Ensuring that the compliance status is discussed agreed and endorsed by the appropriate responsible committee and Executive Lead. Divisional Directors are responsible for: Understanding the CQC guidance and its implications for clinical practice in the Division Ensuring that the guidance and processes are understood by clinicians within their division Escalating clinician areas of concern / non compliance in relation to the outcomes to the Divisional Board Divisional Managers are responsible for: Understanding the quality and safety requirements of registration for all registered activities within their responsibility Within their divisions, ensuring that Service/Business Managers understand the registration requirements of registered activities and ensure that these requirements are met. Reviewing the requirements from information supplied by the Care Quality Commission and any other sources, on a regular basis to ensure there is assurance of compliance within the Division. Where there are issues identified that threaten compliance, or where there are gaps in assurance or lack of controls, ensuring these are suitably managed and reported to the Clinical Governance & Quality Manager and the Outcome Co-ordinator (OC) of the specific area/outcome/regulation where the outcome gap is identified. Page 7 of 38

8 Ensuring that Clinical Directors, Divisional Heads of Nursing and Service/Business Managers are familiar with the requirements of the registration outcomes to support the achievement of Trust-wide compliance and that they cascade requirements through reporting lines. Providing evidence and assurance of compliance to the Outcome Co-ordinator (OC) as appropriate. Ensuring the Clinical Governance and Quality Manager is informed of any changes to Trust activities or services so that the Registration of Activity and Location Spreadsheet (Appendix C) can be updated and the CQC subsequently notified of these changes. Divisional Heads of Nursing are responsible for: Understanding the CQC guidance and Trust assurance processes and ensuring an understanding of requirements by all nursing staff within the division. With Divisional Board colleagues, ensuring the outcome requirements are subject to scrutiny, with reporting, by exception, of areas of concern, both to the Divisional Board and to the OC. Each Specialty has a Clinical Governance Lead Consultant. Clinical Governance Leads are responsible for: Understanding the CQC guidance and Trust assurance processes and ensuring an understanding by clinicians within their specialities. Liaising with the OC where the outcome/regulation dictates clinical involvement and responsibility. Informing the Clinical Director if there are any concerns over compliance with the outcome standards. Ensuring that specialty clinical audits are used to provide assurance in relation to outcome standards and where the audit reveals cause for concern, these are addressed through a monitored action plan. Causes for concern should be notified to the Clinical Director. Service / Business Managers are responsible for: Ensuring compliance with the standards across their services and reporting on compliance to Divisional Management Boards and subsidiary meetings. Page 8 of 38

9 Ensure that evidence to support compliance assurance is easily accessible, preferably electronically, and is organised methodically and catalogued for ease of access. This will ensure that the Trust is always prepared for an unannounced visit by external agencies, and in particular the Care Quality Commission. Providing feedback to the OC, Divisional Board, Clinical Governance & Quality Manager and Divisional Risk Lead, as requested on the compliance status within the service, including any areas of non-compliance / insufficient assurance and actions being taken to resolve this. Through the Divisional Manager, reporting on compliance with the required outcomes through their regular reports to the Divisional Integrated Standards Executive. Divisional Risk Leads are responsible for: Ensuring that they are aware of divisional compliance issues so that they can be addressed, risk assessed and monitored at the Divisional Integrated Standards Executive. Understanding the Trust processes for monitoring compliance and understand the CQC guidance on the essential standards for safety and quality. Through their roles, identify any issues that present risks to compliance of the outcome requirements of registration and ensure they are communicated to the Divisional Board and to the Clinical Governance and Quality Manager. All Staff should have an understanding of the role of the CQC, the outcomes which form part of the essential standards and their responsibilities in contributing to the compliance with these outcomes. Trust Governance Team Responsibilities: Associate Director of Clinical Governance and Risk is responsible for: Promoting the development of the Trust s processes for assurance in relation to the required outcomes such that they are robust, coherent and updated to reflect the requirements for service quality and safety as set out by the Care Quality Commission. Ensuring that Terms of Reference for responsible Committees are reviewed annually in order that they reflect the responsibilities they hold in relation to all aspects of compliance. Ensuring that there is maintained a reporting cycle to the Clinical Governance Committee which robustly pursues the performance management of compliance with registration outcomes. Ensuring that issues, which cannot be resolved through the offices of the Clinical Governance Committee, are escalated as appropriate to the Patient Safety, Quality & Risk Committee, as determined by the nature of the issue. Page 9 of 38

10 Providing support and engagement in areas for which compliance is determined to be challenged, ensuring solutions are developed through liaison with appropriate individuals and Committees. Ensuring that appropriate procedures are followed where a breach in compliance is indicated, to risk assess and action plan and to obtain executive endorsement before notifying the Care Quality Commission in line with registration requirements. Clinical Governance & Quality Manager is responsible for: Operational delivery of the processes of assurance in relation to registration outcomes Monitoring the process of committee review Ensuring that the key assurance committees the Clinical Governance Committee and Patient Safety, Quality & Risk Committee are appropriately managed to reflect their respective terms of reference in relation to CQC responsibilities. Maintain a schedule of standard reporting cycles, which will contribute to the status reports to the Trust Board and to satisfy the external reporting requirements of the Care Quality Commission. With the Outcome Leads, establish a programme of internal scrutiny of compliance using scrutiny panels, developing a peer review approach and using the CQC s litmus test methodology. Through all of the above, identifying issues, which may compromise compliance and escalate as appropriate to the Associate Director of Clinical Governance and Risk, ensuring reports, accompanied by timed action plans, are obtained and placed before the appropriate committee. Ensuring the Registration of Activity and Location Spreadsheet is kept up to date. Ensuring third party locations comply with the registration requirements. Carrying out ward based mock CQC inspections Assurance Coordinator is responsible for: Supporting the Clinical Governance and Quality Manager in coordinating and facilitating the assurance processes for the CQC Registration and Essential Standards of Quality and Safety and undertaking periodic / random reviews of evidence put forward by the outcome coordinators. Responsible Committees: The Trust Board Page 10 of 38

11 Understanding the registration process and implications/impact of the CQC Essential Standards of Quality and Safety. Reviewing the Trust s CQC compliance reports and addressing any areas for which members are not satisfied with the assurances given. Noting outcomes and impact of any CQC inspections on the Trust s compliance with the Essential Standards of Quality and Safety and the actions in place to address any gaps or deficiencies. Reviewing issues for which a notification to the CQC of non compliance may be appropriate and endorsing such notification, based on review of issue and consideration of risks posed to patients The Patient Safety Quality & Risk Committee is responsible for: Ensuring that risks in relation to compliance are appropriately managed and where necessary, to consider high risk issues and make recommendations to the Board as appropriate. Ensuring that all risk registers and the Board Assurance Framework cross reference risks recorded with the relevant registration standard. The Clinical Governance Committee is responsible for: Ensuring processes are in place to appropriately monitor and report on compliance with the Outcomes for Safety and Quality mandated through the registration process. Reviewing, scrutinising and challenging the assurance reports Ensuring the processes of assurance are subject to annual scrutiny through an Internal Audit. Ensuring assurance reports on compliance is submitted to the Board. Divisional Boards are responsible for: Understanding the standards, registration and Trust assurance process Receiving exception reports from Service/Business Managers on areas on concern on the standards within their service areas. Escalating any gaps in assurance relating to the outcome standards to the Outcome Co-ordinator Ensure lapses and breaches have a dated action plan which is monitored for implementation to agreed deadlines. Page 11 of 38

12 The Responsible Committees (Appendix E) are responsible for: Reviewing the requirements of the outcome standard, challenging the compliance status declared and obtaining assurance in relation to the evidence proposed to support compliance. Where there is evidence to suggest non-compliance, the Committee should undertake a risk assessment of the impact on compliance. This should be notified to the Outcome Coordinator and the Clinical Governance and Quality Manager and consideration should be given to recording the risk on a divisional or corporate risk register. Ensuring a programme of audit is incorporated into the Committee s annual work plan to test implementation of requirements. Reviewing outcomes and monitoring implementation of recommendations from the audit. Providing regular third party review (compliance scrutiny panels): - Ensuring the Trust has adequate evidence in support of the compliance status reported by the OC by scrutinising the compliance reports and associated evidence. - Should the compliance scrutiny panel be unable to come to a decision regarding full compliance, areas of concern should be escalated to the Clinical Governance Committee, via the OC, for further discussion. - Providing reports, by exception or as requested to the Clinical Governance Committee / Patient Safety, Quality and Risk Committee. - Provide an opportunity for staff to experience a scrutiny meeting modelling the approach to be used should the Trust receive an inspection visit from the Care Quality Commission. 6. Registration of Activity, Service and Location The Clinical Governance and Quality Manager will maintain the Registration of Activity, Service and Location spreadsheet (appendix C). Business/General/Service Managers must inform the Clinical Governance and Quality Manager of any changes to services provided or their locations. Any changes must then be notified to the CQC by the nominated lead. The registration spreadsheet will be circulated every six months for review and updating. 7. The Quality & Risk Profile The Quality and Risk Profile is a constant check on all the information about WHHT that is available to the CQC. The CQC will involve and gather information from people who use your services, public representative groups and other agencies and regulators. The information they gather during a review of our service will also feed back into the QRP. The CQC will use all this information Page 12 of 38

13 to make judgements about the level of risk of WHHT not meeting the essential standards, the frequency of planned reviews, and whether they need to follow up on concerns. 8. The Trusts Assurance Process 8.1 Provider Compliance Assessments (PCA) The PCA is the CQCs preferred process for Trusts to monitor and gain internal assurances of compliance or non compliance. PCAs will be completed on a six monthly basis for each of the 16 Quality and Safety Outcomes. The PCA includes the following: Outcome Name Summary of the leads, contributors and responsible committee Latest QRP Risk Estimate Summary of compliance (preferably outcome based) Description of the levels of compliance Action Plans in place The Outcome Co-ordinator is responsible for reviewing the assurance/evidence in relation to the outcome and the specific prompts and amending, updating and adding assurance where appropriate. It is not necessary to add all supporting evidence (i.e. audits, minutes, reports etc) to the PCA although a snap shot of more recent outcome evidence to support the assurances is required. Levels of compliance will be graded as follows: Compliant Non Compliant - Minor Concern Where minor concerns are identified, people who use the service are safe, but the provision of care may not always meet this safety and quality regulation. Moderate Concern Where moderate concerns are identified, people who use the service are generally safe, but there are risks to their outcome, health and wellbeing. Provision of care is inconsistent and may not always meet this safety and quality regulation. Major Concern Where major concerns are identified, people who use the service are not protected from unsafe or inappropriate care. The provision of care does not meet this safety and quality regulation. Once the PCA has been completed it needs to ed for sign off by the Executive Lead and reviewed at the responsible committee. Any action plans within the PCA need to be updated Page 13 of 38

14 8.2 CQC Assurance Reports (Process for Monitoring Compliance & Effectiveness) Provider Compliance Assessments (PCA) will be undertaken every six months and reviewed at the responsible committee A six monthly compliance statement for each outcome will form part of the CQC Assurance Summary Report which will be presented at the Patient Safety, Quality and Risk Committee. Any concerns or assurance gaps identified outside of the reporting schedule will be escalated as additional reports (i.e. Mock ward inspections) 8.3 Evidence Repository Arrangements for evidence storing are suggested as follows: Each Outcome Coordinator should maintain an evidence repository. Divisions and Corporate Functions should ensure their evidence is available by liasing with the Outcome Co-ordinator as appropriate. It is the responsibility of the Outcome Co-ordinator to ensure that the evidence meets the criteria set out in guidance (see What is outcome evidence on the CQC registration section of Risk Management site on Trust intranet). 9. CQC Unannounced Inspections The CQC will carry out planned and responsive reviews of the Trusts compliance A review of compliance is a review of the outcomes and experiences of people using the service, to determine whether the essential standards are being met. It is an assessment of care, treatment and support delivered by the Trust through the assessment of outcomes for people who use services. In a review, the CQC will reach a judgement about compliance. They do this by analysing the information that they gather from a range of sources, including people who use services, the public, and partners such as commissioners and regulators. Where they identify concerns with compliance or noncompliance, they will take regulatory action to encourage improvements, to ensure that people who use services experience the care, treatment and support they should. They will also use a review of compliance to check that necessary improvements have been made. 9.1 Planned Inspections This is a programme of planned reviews in which every location is reviewed at least once every two years. Page 14 of 38

15 The CQC will carry out planned reviews more frequently, the shortest timespan is every three months where they are concerned about the quality of care at a location or where a provider is carrying out high risk activities. They do not normally give providers advance notice of a review of compliance. However, they will say whether it is a routine review, or whether it is in response to concerns. A planned review is a full check of the 16 essential standards that most directly relate to the quality and safety of care. If they visit, they will focus on the outcomes they expect people who use services to experience. They will directly observe the care being provided, and talk to the people who are using your services and our staff. They may also review the records of people who use your services to assess the outcomes they experienced. 9.2 Responsive Inspections If, at any time, the CQC have concerns that the Trust are not meeting the essential standards, they can carry out a responsive review. This would be triggered by specific information they receive that highlights concerns. A responsive review is not a full check of compliance with the 16 essential standards. Instead it targets the areas of concern and the standards to which they relate. It may include a visit. 9.3 Following inspection Once the CQC have gathered and analysed all the information, they will make a judgement about whether the Trust is meeting the essential standards. If the Trust is not meeting the standards, they will look at the impact of their concerns on people using your service and the likelihood that these will happen again. Where issues can be resolved quickly and easily, they may simply discuss them with the Trust. If the Trust is meeting the essential standards, but the CQC have concerns that the Trust may not continue to do so, they may set an improvement action and ask the Trust to send a report stating how we will make improvements. If the Trust is not meeting essential standards, which means we are not complying with the regulations, the CQC may set a compliance action. This also requires the Trust to send a report stating how you will make the necessary improvements. If improvements are not made, they may decide to take enforcement action. The CQC will always follow up improvement and compliance actions to check that the necessary improvements have been made. If services are not meeting the essential standards and are failing to provide safe care to people using them, they have a wide range of enforcement powers that allow us to take swift action. This includes sending out warning notices, imposing conditions, charging fines, suspending registration and prosecution. As a last resort they can cancel a Trusts registration. 9.4 Inspection Report & Action Plan (Process for Monitoring Compliance & Effectiveness) Page 15 of 38

16 When the CQC have completed a review of compliance, they will send the Trust a report as soon as possible setting out their findings, and judgements about compliance. The Inspection report will be received by the Chief Executive and the Associate Director for Clinical Governance and Risk who is responsible for ensuring that the report is circulated to the following individuals: All Executive Directors Divisional Manager (of the location/specialty where the inspection took place) Clinical Director (of the location/specialty where the inspection took place) Head of Nursing (of the location/specialty where the inspection took place) Matron / Manager (of the location/specialty where the inspection took place) Outcome Leads The Trust will have 14 days to check the report for factual accuracy. The Associate Director for Clinical Governance and Risk is responsible for ensuring that the report is reviewed at the appropriate committees: Trust Board Patient Safety, Quality and Risk Committee The Associate Director for Clinical Governance and Risk is responsible for ensuring that if any improvements or actions are required then these are developed into an action plan, progress against these actions is monitored and once completed sent to the CQC. Action plan implementation and progress/monitoring will take place at the responsible committees and Patient Safety, Quality and Risk Committee: The completed action plan will be signed off at: Patient Safety Quality and Risk Committee Page 16 of 38

17 Appendix A - The PCA Process for Outcome Coordinators Outcomes assigned to Outcome Coordinator (OC) and Executive Lead (EL) Outcome Coordinator (OC) Brief Responsible Committee on the requirements and sources of evidence of compliance. Committee adds to agenda/reporting cycle Business / General / Service Managers must inform the OL of any outcome concerns within their areas/services Business Managers must inform the Clinical Governance & Quality Manager of any changes to services Meet / discuss with other contributors to determine status of compliance Review outcome evidence and be assured that all evidence is available and current. Complete compliance report (PCA) Develop any action plans to address gaps in assurance and mitigate risks and escalate to Responsible Committee PCA to EL for review and agreement of compliance status Compliance report signed off by both OC and EL Patient Safety Quality & Risk Committee reviews summary compliance report Any non-compliance statements/concerns are escalated to Chief Executive (NI) for review EXECUTIVE LEAD (EL) Summary compliance report reviewed at Trust Board Page 17 of 38

18 Appendix B Provide Compliance Assessment (Example) WHHT CQC Provider Compliance Assessment Outcome Quarter Director Lead Outcome Lead Responsible Committee Last CQC Risk Estimate 1. Summary of Trust Assurance 2. Assessment Essential Standard Quality Safety of and Compliant Minor Concern Where minor concerns are identified, people who use the service are safe, but the provision of care may not always meet this safety and quality regulation. Non Compliant Moderate Concern Where moderate concerns are identified, people who use the service are generally safe, but there are risks to their outcome, health and wellbeing. Provision of care is inconsistent and may not always meet this safety and quality regulation. Major Concern Where major concerns are identified, people who use the service are not protected from unsafe or inappropriate care. The provision of care does not meet this safety and quality regulation. Outcome 3. Action Plan Action Lead Deadline

19 Appendix C - Registration of Activity, Service and Location Spreadsheet. This appendix is an example of the live document Registered Activity Personal Care Accommodation for people who require nursing or personal care Description Services (provided within each type of regulated activity) Location (s) Physical assistance given to a person in connection to eating, drinking, toileting, washing, dressing, care of skin or the prompting or supervison or the activity. Personal care represents a social care service and activities outside that context will not be registered. Where accomodation is provided alongside personal care (e.g. a nursing home) Not applicable to WHHT as the Trust will register for Treatment where personal care is provided as part of this treatment. Not Applicable to WHHT Not Applicable to WHHT Accommodation for people who require treatment for substance misuse Accommodation and nursing or personal care in further education sector Accomodation and Treatment for people recovering from an addiction. This activity does not apply to hospitals that provide detoxification treatments for substance misuse. This activity will include care homes and care homes with nursing that are provided with further education. Not Applicable to WHHT Not Applicable to WHHT

20 Registered Activity Transport services, triage and medical advice provided remotely Treatment of Disease, Disorder or Injury Description Services (provided within each type of regulated activity) Location (s) Services are captured by this regulated activity where they involve a vehicle that was designed for the primary purpose of transporting poepl e who require treatment, CQC view is that this regulated activity will normally cover routine, planned patient transport related to treatment. This activity allows for any treatment service that is provided by a healthcare professional or by a multidisciplinary team, it will include a wide range of treatment such as emergency treatment, ongoing treatment for long term conditions. It applies from hospitals to clinics and community services. Treatment of disease, disorder or injury does not include surgical procedures as these are covered by a separate treatment. Diagnostic procedures and investigations provided as part of treatment will be included within this activity. However standalone diagnostic services are covered by a separate activity. Transport services are out sourced to a contractor with a Service Level Agreement Medical Services Limited This company is registered with the Care Quality Commission for Transport Services. Rheumatology. Rheumatology also takes place at Harpenden Memorial, the building is owned by the PCT but the Trust runs outpatient clinics staffed by Trust employees for WHHT patients, these patients do not stay overnight nor are beds, trolley's, couches, reclining chairs provided for the purpose of post procedural recovery from procedures, it is a satellite outpatient clinic which serves WHHT and therefore is included in the registration location of WHHT at regardless of geographical location. Not Applicable to WHHT HHGH,,

21 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Nephrology. Nephrology is provided at by Imperial for WHHT patients by imperial staff, services are provided by Imperial on WHHT premises for the benefit of WHHT service users. WHHT holds the responsibility under the regulated activities regulations for ensuring that the staff it is using from Imperial meet the regulated requirements and is overall accountable for the delivery of that service even though its is being delivered by Imperial staff. WHHT has registered this service. Anticoagulation, HHGH, Neurology HHGH,, Respiratory (Thoracic Medicine/COPD) HHGH,, Emergency Care (Split into sections below) Accident and Emergency Minor Injuries Unit Urgent Care Centre. GP's are subcontracted from Herts Urgent Care, nursing staff are supplied by WHHT. The Trust has registered this activity. HHGH Endocrinology and Diabetes, HHGH, Care of the Elderly, HHGH, Stroke Acute Unit Stroke Rehab Unit HHGH

22 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Sexual Health & Genito Urinary Medicine HIV Clinics/Service. Based at with some outreach services., General Medicine, HHGH & Outpatient clinics Dermatology. Some patients are seen at Harpenden Memorial by WHHT consultants, satellite outpatient clinic, registered under the address regardless of geographical location. Dermatology CATS service., HHGH,, Trust uses GP surgery's and potters bar hospital for WHHT patients, registered under the address. Intensive Care Unit / HDU Cardiology,, HHGH Echocardiology Catheter Labs HHGH, Cardiac Physiology HHGH,, Gastroenterology. Some patients are seen at Harpenden Memorial by WHHT consultants, satellite outpatient clinic, registered under the address regardless of geographical location Endoscopy Clinical Haematology, HHGH, HHGH,

23 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Clinical Haematology Outpatients HHGH Oncology Outpatients, HHGH, Fracture Clinic, HHGH Phlebotomy HHGH,, Oncology Gynaecology inpatient service Gynaecology outpatients. Outpatients is provided at Harpenden Memorial, the PCT is the host but WHHT provide the service which has been registered under the address. Gynae emergency service Gynae day assessment unit, HHGH, Pain service (outpatients), HHGH, Medihome (this service is provided by Medihome staff in patients homes following early discharge, the service is used mainly but not limited to Orthopaedics/AAU). WHHT contract Medihome to do this although patients are still registered under WHHT care as they have not been discharged from WHHT - patients just receive their care at home rather than in hospital, as this service is offered in patient s homes it is registered at the address. Colposcopy Clinical Immunology Paediatric Medicine, HHGH

24 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Surgical Appliances.,,HHGH, Surgical Procedures All surgical procedures are carried out by a healthcare professional are captured by this activity excluding minor nail bed procedures and minor surgery under local anaesthetic often referred to The Trust has a Service Level Agreement with a private company (Trulife) that provides an Orthotic service for the Trust, they operate on Trust premises and treat our patients. Therapies (Clinical psychologists, occupational therapists, physiotherapists and speech and language therapists are not included in the list of registered healthcare professionals and stand alone services run by these professionals are not required to register, but where such professionals work in multi-disciplinary teams with staff listed as registered healthcare professionals (i.e. nurse, medical practitioner etc) then the service will need to be registered and the registered provider must ensure compliance in all aspects of the treatment provided.) Dietetics Occupational Therapy Physiotherapy Paediatrics Childrens Emergency Department Paediatrics inpatient including HDU Ambulatory care,hhgh,,hhgh,,hhgh, Childrens Outpatients, HHGH, General Surgery. Some patients are seen at Harpenden Memorial by WHHT consultants, satellite outpatient clinic, registered under the address.,

25 Registered Activity Description Services (provided within each type of regulated activity) Location (s) as lumps and bumps. Orthopaedics., Some patients are seen at Harpenden Memorial by WHHT consultants, satellite outpatient clinic, registered under the address. Anaesthesia Intensive Care Unit / HDU (following major surgery) Trauma Emergency Surgery ENT ENT Outpatients Oral Maxillo Facial Ophthalmology (outpatient treatments) Ophthalmology (outpatient treatments and surgery) Upper GI Surgery Vascular Surgery Breast Surgery Day Surgery Oral MaxilloFacial Colo-rectal Surgery,,, HHGH,,,, Pain Services (outpatients and treatment),, HHGH Pain Services (Surgery) Gynaecology,

26 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Oral Surgery Cancer Clinic Orthodontics Paediatric Surgery Urology WHHT may outsource any of the above surgical procedures to an independent hospital provider for the use of their premises; WHHT is the provider as it holds overall responsibility for the patients even though they are being treated in the independent hospitals facilities. WHHT exercises its responsibility for ensuring that the parts of the independent providers premises it is using for carrying on the regulated activity meets relevant regulations and that staff providing care or treatment for its patients satisfy the 'fitness' regulations. Some patients for various surgical specialties are seen at the satellite outpatient clinic at the Memorial Hospital, these are purely outpatient appointments and no procedures take place. In this case the registered location is. / Gynaecology Surgery Outpatients and Day Surgery Gynaecology Surgery Inpatient Gynae Cancer Services. WHHT host the Gynae centre for women in Herts and Beds, the service is provided by our doctors and visiting gynaecology oncologists from L+D and E&N Herts. The Trust provides the service. Hand Surgery Hand Surgery Clinics / Outpatients (Only) HHGH

27 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Diagnostic screening procedures and This activity includes all diagnosticimaging services. Pathology (Hot), HHGH (Cold) Andrology HHGH, Anticoagulation,HHGH, Blood Transfusion Chemistry (Hot ), HHGH (Cold) Cytology Haematology (Hot ), HHGH (Cold) Immunology HHGH Histopathology. HHGH/* *Histopathology based/hosted at Mount Vernon will need to be registered at the Trusts address it services our patients and Royal Free Plastics Phlebotomy Phlebotomy Outreach Service to GP's Microbiology Mortuary Body Store /HHGH/ HHGH HHGH, HHGH, HHGH, POCT HHGH,, NEQAS -autonomous (national service not a specific WHHT one) Radiology CT, HHGH

28 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Fluoroscopy, HHGH, Fluoroscopy - Interventional Mammography MRI Nuclear Medicine X Ray Ultrasound - Non - obstetric Ultrasound - obstetric, HHGH, HHGH,, HH,, HH,, HH Pharmacy Dispensary, HHGH, Stores Technical Services Tablet Packing Unit Catheter Labs (Cath Labs also listed as they fall under this category "All diagnostic procedures involving the use of any form of radiation, including x-ray) Maternity and Midwifery Services Maternity and Midwifery services are an activity in their own right Maternity Midwifery led antenatal service. The community service which is run at GP practices, health centres and Children's centres are not hosted by the Trust but are the Trusts responsibility as it hold overall responsibility for the patients, these locations fall under the, HHGH,

29 Registered Activity Description Services (provided within each type of regulated activity) Location (s) location of the Trusts address. Obstetrics led antenatal, HHGH, Fetal Medicine including scanning Maternity day assessment unit Midwifery led intrapartum. This is also provided at home which will be registered at the location of the Trusts address. Obstetrics led intrapartum Post natal Post natal community service. Services in the community will be registered at Trusts address, HHGH,

30 Registered Activity Description Services (provided within each type of regulated activity) Location (s) Maternity Knustford (). The Trust has a 6-bedded private postnatal facility; private patients pay the Trust for care and accommodation and separately pay a Trust consultant who will then operate privately (private obstetric practice takes place on the main delivery suite) following Trust procedures. The Trust will be registering this service in that doctors rent consulting rooms for private outpatient appointments, these doctors provide a consultation within a service that is managed by the Trust, this means that all aspects of the consultation is carried out under the hospitals management and policies. The Trust will also be registering this service as it provides the postnatal nursing care and accommodation. Neonatal Service (NICU). Level 2. The Trust also provides a community neonatal service, home visiting but this will be registered at address. Termination pregnancies of Women requesting termination of pregnancy for non-medical reasons are referred to private organisations commissioned by the PCT. Medical Terminations

31 Registered Activity Nursing Care Description Services (provided within each type of regulated activity) Location (s) General nursing care will fall under treatment, however where nursing care is provided that is not part of another activity the provider must register e.g. health visiting service or sexual health advisory service. Where other forms of contraception are fitted or supplied, such as a contraceptive cap, diaphragm or oral or injectable contraception, then these are exempt from the activity of family planning. However, they will be included in the activity of nursing care if carried out by a registered nurse. The Trust runs nurse led Contraception sessions where other forms of contraception are supplied/fitted. The service is based at with 6 satellite clinics at, Elstree Way, Garston, Hemel Hempstead, Potters Bar, St.Albans and South Oxhey, these community clinics, are registered under the address regardless of geographical location.

32 Registered Activity Sexual Services Health Description Services (provided within each type of regulated activity) Location (s) Full contraceptive services (including LARC s) are provided by WHHT from two hospital-based clinics (Watford and St.Albans) and six community-based clinics. Services include insertion and removal of intrauterine contraceptive devices and Implanon. These are singled out as an activity in their own right because they do not constitute as treatment as such. Contraceptive Services. These services are based at, with some done at. The majority of the service (other than at ) is based in the community. For the purpose of the registration these clinics are registered under head office. Genitourinary Medicine services are provided from Watford and St.Albans Sexual health Centres based in hospital grounds. Services offered include Level 3 Sexual Health service which comprises of specialised infection management including screening (including HIV testing), advice, treatment and co-ordination of partner notification The HIV team are based at Watford Sexual health Centre but also run outreach clinics in community settings, providing support and treatment for people living with and affected by HIV., Assessment or medical treatment for people detained under the Mental Health Act 1983 Inpatient's admitted to West Hertfordshire NHS Trust may require detention under the MHA 1983, in an emergency the doctor in charge of the treatment will need to initiate a 72 hour holding power over the patient, preventing them from leaving hospital and allowing time for consideration to be given as to whether an application should be made for further detention. Mental Health detention may take place within any inpatient services provided by the Trust, HHGH,