Policy for Care Quality Commission Essential standards of quality and safety self assessment and assurance process

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1 Policy No: RM76 Version: 1.1 Name of Policy: Essential standards of quality and safety self assessment and assurance process Effective From: 25/04/2013 Date Ratified 15/03/2013 Ratified Patient, Quality, Risk and Safety Committee Review Date 01/03/2015 Sponsor Director of Nursing, Midwifery and Quality Expiry Date 14/03/2016 Withdrawn Date This policy supersedes all previous issues.

2 Version Control Version Release Author/reviewer Ratified by/authorised by /04/2013 Mrs Sue Winn, Head of Compliance and Assurance Patient, Quality, Risk and Safety (PQRS) Committee Date 15/03/2013 Changes (Please identify page no.) /04/2013 Mrs Sue Winn, Head of Compliance and Assurance Director of Nursing, Midwifery and Quality 22/04/13 Requirements for review of statement of purpose 2

3 Contents 1. Introduction Scope Aim Duties roles and responsibilities Definition of terms The self assessment process Self assessment Guidance Risk factors Training Equality and diversity Process for monitoring compliance Consultation and review Process for implementation References Associated documentation Appendices 1. Governance declaration template CQC action plan template Quarterly self assessment submission deadlines Terms of Reference CQC Assurance Board (to be completed)

4 1. Introduction 2. Scope 3. Aim All providers of health and adult social care in England must be registered to provide care with the Care Quality Commission (CQC) in compliance with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2012 and the Care Quality Commission (Registration) Regulations Each provider s registration with the CQC is dependent upon their ability to evidence their compliance with all 28 of the CQC s essential standards of quality and safety. Once registered with the CQC, all providers of health and adult social care in England must continue to evidence their compliance with the CQC s essential standards of quality and safety on an on going basis. This compliance will be checked by the CQC using both planned and unannounced site inspections. This guidance is designed to support Owners, Sponsors and divisional directors/divisional managers to undertake robust self assessment of the extent to which their division is compliant with each of the 16 essential standards most directly related to patient care. The Trust uses the Provider Compliance Assessment (PCA) tools issued by the CQC, which are used to assess whether the organisation is compliant with each of the Outcomes. The manual collection and collation of evidence has proved to be time consuming resulting in a duplication of effort and work within and across divisions/departments and at a corporate level in the Trust. To simplify the process and gain more valid assurance that all parts of the organisation are compliant, an e compliance system Health Assure is being implemented and this policy has been created to support the implementation and on going process of self assessments and assurance on a regular basis. This policy relates to the quarterly self assessments of compliance with the CQC s 16 essential standards most directly related to patient care undertaken by divisions within the Gateshead Health NHS Foundation Trust. This includes all locations registered for regulated activities as required by the CQC. This guidance is designed to provide structure to support a regular robust self assessment of the extent to which each division is compliant with each of the 16 essential standards most directly related to patient care to provide assurance to the Trust Board on a regular basis that CQC registration requirements continue to be met. 4. Duties; roles and responsibilities Chief Executive: As accountable person for the Gateshead NHS Foundation Trust, the Chief Executive is responsible for ensuring that the organisation has full compliance at all times against the CQC Regulations. This responsibility is delegated to the Director of Nursing, Midwifery and Quality. 4

5 Director of Nursing, Midwifery and Quality: The Director of Nursing, Midwifery and Quality has delegated responsibility for ensuring compliance with all Outcomes of the CQC Regulations. Head of Compliance and Assurance: the Head of Compliance and Assurance is responsible for the management of the process to ensure appropriate registration with the CQC and the system for providing assurance of compliance against the CQC essential standards of quality and safety. In addition, the Head of Compliance and Assurance is responsible for organising the Trust s response to any planned or unannounced visits by Regulators. There are two areas of responsibilities for Provider Compliance Assessments (PCAs): Responsibility for the corporate PCAs and responsibility for the departmental PCAs. Corporate Outcome Provider Compliance Assessment: Executive Directors: Each Executive Director has been identified as a Corporate CQC Sponsor for a number of the Outcomes depending on their remit. Each executive director has a responsibility to oversee appropriate completion of the evidence in relation to those Outcomes within their portfolio. Corporate CQC Outcome Owners (Outcome Lead): Corporate CQC Outcome Owners are lead staff who have a special interest/remit or have a Trust wide responsibility for an outcome area e.g. nutrition. These Outcome Leads are responsible for making sure that the relevant corporate documentation is identified and available and for reviewing the corporate PCA in the specialism to provide support to divisions where there are gaps. As the Corporate Outcome Lead, responsibility will include ensuring that the updated Corporate PCA is reviewed and approved by the relevant committee on a regular basis (minimum six monthly). Departmental/divisional Outcome Provider Compliance Assessment: Departmental CQC Owners: The CQC Departmental Owner is the person who undertakes the self assessment of compliance for their department on the Health Assure (Performance Accelerator) system and who uploads evidence to the system. Departmental Owners are generally matron s or heads of service and are identified by their portfolio through the divisional manager or assistant divisional manager. They will liaise with the Divisional CQC Sponsor to identify actions to be taken to ensure that assurance is available to demonstrate that each relevant Outcome is fully compliant within their department. Divisional CQC Sponsors: The CQC Divisional Sponsor is the more senior member of staff (e.g. assistant divisional manager) who validates the Owner s self assessment of compliance and the evidence uploaded to the system. They are responsible for providing the divisional manager/directors with the relevant regular reports and dashboards to enable them to be assured of compliance throughout their division and to make an informed sign off of the self assessment Governance Declaration. The CQC Divisional 5

6 Sponsor will be responsible for ensuring action plans are developed when gaps in assurance are identified. Shared users: Are staff who are identified to support either CQC owners or Corporate CQC owners to support the collation and upload of information into the Health Assure system. Divisional Directors and Divisional Managers (Associate Directors): Divisional directors and divisional managers (associate directors) have joint responsibility for their areas to review the divisional dashboards and reports and sign off the quarterly self assessment declaration in relation to those of the 16 Outcomes which are relevant to their division. They will be responsible for attending the CQC Assurance Board as necessary to report on actions in relation to gaps in assurance, any risk to compliance or failure to complete the process to declare compliance. Divisional directors and associate directors are also responsible for reviewing the statement of purpose on a quarterly basis and either confirming it s accuracy or notifying of any amendments with the declaration of compliance. Any amendments between the quarterly review must be forwarded to the Head of Compliance for the submission of timely changes to the Trust CQC registration document. All staff: All staff have a responsibility to ensure compliance with the policies and guidelines of the organisation to provide an appropriate level of care and compliance with the CQC essential standards. CQC Assurance Board: The CQC Assurance Board will meet at least quarterly to review the quarterly self assessments, action plans and monitor progress on action plans. The CQC Assurance Board will prepare and submit a six monthly report to the Patient, Quality, Risk and Safety (PQRS) Committee. The Terms of Reference are at appendix 4 5. Definition of terms CQC Care Quality Commission The term Departmental CQC Owner is used to denote the person who undertakes the self assessment of compliance on the Health Assure system on behalf of the department and who uploads evidence to the system. The term Divisional CQC Sponsor is used to denote the more senior member of staff (e.g. assistant divisional manager) who validates the Owner s self assessment of compliance and the evidence uploaded to the system. The term Corporate CQC Sponsor is used to denote the executive directors who have an over arching responsibility for the management of the evidence and self assessment process in respect of the subject area of the Outcome. The term Corporate CQC Outcome owners are the Outcome Leads who have responsibility for a specific outcome depending on their specialism/portfolio. The term Shared users are staff identified to support the CQC Owner identify and upload the relevant evidence to the Health Assure system. 6

7 Provider Compliance Assessment (PCA). Document/tool provided by the CQC that outlines the requirements of each Outcome and provides the basis for the self assessment against the requirements required by the Health and Social Care Act. 6. Self assessment process 6.1 Self assessment Every quarter all divisions must: i) Carry out a refresh of their self assessment of compliance against the CQC Outcomes on Health Assure before the deadline. ii) If any outcomes are assessed as amber or red, create a CQC action plan describing the action to be taken to assure compliance in time for the next quarter s self assessment. iii) Discuss and agree the division s self assessment of compliance, CQC action plan (if required) and Governance Declaration at the service s clinical governance meeting. iv) Review the statement of purpose and confirm it s accuracy or notify any changes along with the signed declaration. v) Sign the appropriate Governance Declaration vi) Submit their Governance Declaration, CQC action plan (if required) and clinical governance meeting minutes for the period to the Head of Compliance and Assurance by the relevant deadline vii) Attend the CQC Assurance Board as necessary to report on actions in relation to gaps in assurance 6.2 Guidance a) For each of the CQC s Outcomes the division should complete the CQC s Provider Compliance Assessment (PCA) tool on at least one occasion. The use of this tool is advised by the CQC to enable services to holistically and robustly assess their compliance against each element of each of the Outcomes. The tool provides the division with the opportunity to RAG rate their compliance against each element of the outcome. The RAG ratings are the same as those used on the Health Assure system which ensures consistency. The PCA also enables the divisions to list the documents it considers demonstrate that the Outcome is being met for people who use the service. By completing these sections the division can be clear what evidence it has and can also identify where one piece of evidence can be used to evidence multiple elements of each Outcome or multiple Outcomes themselves. Having an up to date log of the evidence used on the division s part of the Health Assure system means that when that piece of evidence is updated it 7

8 is easy to identify where the updated evidence needs to be uploaded onto the Health Assure System. The PCA also contains sections after each Outcome element for the division to detail any improvement action it needs to take in order to fully evidence compliance with that element of the Outcome. When viewed as a whole document each improvement action box within the PCA will create an overarching action plan for improvement of the division s evidence against that particular Outcome. Best practice indicates that each Outcome s PCA document should be revised by the division on a fairly regular basis (6 monthly). b) When using the Provider Compliance Assessment (PCA) tool to assess the division s level of compliance, reference should be made to the Guidance about compliance, essential standards of quality and safety, (March 2012, CQC) document available in either hard copy or electronic copy from the CQC s website (see section 12 for web link). This document provides all the information required by a division to assess its compliance with each outcome. It is therefore the most important document to be used when undertaking the division s self assessment of compliance. Extracts from the document are available for reference on the Health Assure system but divisions may find it easier to refer to the full hard copy or electronic document. c) Undertake spot checks of compliance against one Outcome each quarter. The CQC undertake both planned and unannounced visits to check a provider s compliance with their essential standards. In order to anticipate what the CQC might find during such a visit divisions should undertake spot checks against a specific outcome (or a number of outcomes) within their own services that is not already the focus of another type of spot check (e.g. senior nurse walk around, infection control audits, etc.) Such spot checks could be unannounced or planned. The spot check could be carried out by either a member of staff from within the division or it could be carried out by a member of staff from a different division or department (a peer review). To provide a framework for such spot checks the division should refer to the CQC s Observation Guides which have been written to assist the CQC s own inspectors to assess whether the care they observe on inspections provides evidence of compliance or non compliance. Section 12 includes a link to the document on the CQC website. Once completed, the reports from these spot checks will provide robust evidence of the division s compliance and can be uploaded to the Health Assure system. 8

9 d) Access the specialist knowledge of Corporate Outcome Owners/Outcome Leads and Trust leads. In a number of Outcomes the divisions may find it helpful to access support and advice from one of the Trust s leads for specific activities. For example Outcome 10: Safety and suitability of premises requires the division to have. Planned and practised fire evacuation procedures. Clearly it is not possible in some areas to regularly practise fire evacuation procedures. However, the Trust s Fire Advisor is available to support divisions in drawing up evacuation plans and carrying out desktop evacuation procedures which again provide excellent evidence of compliance with this aspect of Outcome 10. Corporate Outcome Owners/Outcome Leads will review corporate documents that comprise relevant evidence and forward these to the divisional/departmental owners through the Health Assure system. This will assist in reducing duplication in effort by sharing relevant documents and assist in ensuring consistency across the organisation. e) Utilise a broad range of documents as evidence. Divisions should make full use of the documents they have to provide evidence of compliance against the Outcomes. Annual fire risk assessments provide good evidence against Outcome 10: Safety and suitability of premises. National inpatient and outpatient surveys and comment cards provide evidence against Outcome 16: Assessing and monitoring the quality of service provision. CLIPA (Complaints, litigation, incidents and PALs) reports will support the evidence required in relation to incident reporting. f) As a minimum the following documents should be used as evidence of compliance or non compliance against the Outcomes: Complaints, claims/litigation (clinical negligence and employee or public liability) and incident reports and risk assessments Visits from external agencies e.g. CQC, NHS Litigation Authority, Health & Safety Executive, Screening Programme Quality Assurance inspections, MHRA inspections, Royal College visits. Audits (e.g. clinical audits, internal audits, external audits, infection control audits, PEAT visits) Patient feedback: e.g. comment cards, patient surveys, compliance, focus groups Performance reports, Trust Board assurance reports where available g) Corporate policies should not be the only evidence of the division s compliance. Knowing about and uploading the current version of a corporate policy is only one aspect of evidencing compliance: it shows that the division is aware that the policy exists. However the division needs to also evidence that it adheres to the policy s content. Every policy has a 9

10 monitoring table. The division should undertake a self assessment of its compliance with the content of the monitoring table. Such a selfassessment need not take long but should be documented and the results of the self assessment and any actions to be taken to improve compliance should be uploaded against the Outcome to which the policy relates. h) Make use of different types of evidence. The CQC s document entitled Using evidence of outcomes to demonstrate compliance, Guidance for providers illustrates the wide range of different types of evidence divisions should use to evidence their compliance against the Outcomes. (See Section 12 for the CQC website link). All the evidence gathered by the division and uploaded to Health Assure is valuable, however the CQC advise that services should: focus particularly on evidence that: Comes directly from people who use services and those acting on their behalf. Relates to the experiences of individual people who use the service. Your evidence should also demonstrate: How you assess people s needs appropriately and adequately, and how these needs are met. How you address and minimise risks to the health, welfare and safety of people How you listen to and act on feedback The results of improvements made following changes in practice. 1 i) Ensure multi disciplinary validation of self assessment of compliance and evidence uploaded to Health Assure. The care provided by divisions is a result of multidisciplinary teams working together. Equally the validation of the division s self assessment of compliance with the CQC s essential standards should be multi faceted. The divisional director, divisional manager, the assistant divisional manager and the matron/department/service manager must discuss and agree both the selfassessment of compliance and the evidence which has been uploaded to Health Assure. Prior to the final submission of the self assessment, evidence and action plans they must be discussed and agreed at the division s clinical governance meeting. By approving the division s self assessment and evidence on Health Assure the divisional director/manager is confirming that representatives of all professions within the division have agreed to the self assessment and that the evidence is an accurate representation of the services provided to patients. 1 Using evidence of outcomes to demonstrate compliance, Guidance for providers, September

11 j) Refer to the Trust s Quality and Risk Profile (QRP) when undertaking the division s self assessment of compliance. Every month the CQC publishes this document known as the QRP. For the CQC the QRP is an essential tool for providers, commissioners and the CQC s own staff in monitoring compliance with the essential standards of quality and safety. The QRP assists the CQC to assess where risks lie and should therefore play a key role in the trust s own internal monitoring of compliance. The QRP draws in data from a number of sources which the CQC analyses to identify areas of potential non compliance within a provider. This is done by producing a set of risk estimates of non compliance, one for each of the 16 essential standards. If these risk estimates raise questions about a provider s compliance with the 16 essential standards the CQC may respond with front line regulatory action e.g. scheduling inspections or making targeted enquiries. The information within the QRP is drawn from a wide variety of sources including: Other regularly bodies for example the National Patient Safety Agency The NHS Litigation Authority Routine data collections for example Hospital Episode Statistics and estates return information collection Other CQC regulatory activity for example monitoring of compliance with the regulation on cleanliness and infection control. National clinical audit datasets Information from people using services for example NHS Choices and feedback from Health Watch The QRP is automatically uploaded to the Health Assure system therefore the data is available for view in the QRP module. k) CQC Assurance Board With reference to section 4, the divisional director and divisional manager will be required to attend the CQC Assurance Board as required to review and discuss the division s self assessment and associated action plans. Executive directors and Corporate Outcome Owners (Outcome Leads) may also be invited to attend as required. 6.3 Risk factors Without robust self assessments of compliance undertaken on a regular basis by division s there is a risk that the Trust may be unaware of compliance issues until an external regulator discovers them during an inspection, with the resulting negative impact upon the trust s reputation. 11

12 Support is available to all divisions from risk management in relation to any aspect of the CQC compliance self assessment process. In addition, the Head of Compliance and Assurance is responsible for organising the Trust s response to any planned or unannounced visits by regulators 7. Training The Health Assure System Administrator will provide training on the process as detailed within this document in workshops and relevant meetings across the Trust. A programme of training on the use of the e compliance Health Assure System will be developed for Owners and Sponsors prior to the roll out of the system. 8. Equality and diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on the grounds of any protected characteristic (Equality Act 2010). An equality analysis has been undertaken for this policy, in accordance with the Equality Act (2010). 9. Process for monitoring compliance with the guidance Standard/process/issue Adherence to quarterly submission deadline Monitoring and audit Method By Committee Frequency Through quarterly Quarterly validation process Head of Compliance and Assurance CQC Assurance Board Level of assurance available, issues with compliance with the Outcomes, compliance with the process for action plans. Overarching report Head of Compliance and Assurance PQRS + Trust Board Six monthly 10. Consultation and review This guidance will be reviewed every three years or earlier if the Care Quality Commission makes significant changes to its essential standards of quality and safety. Consultation on the policy included review by Central Team, divisional directors, divisional managers, assistant divisional managers, matrons, heads of department, 11. Process for implementation This guideline will be implemented in association with the project for the implementation of the Health Assure e compliance system. 12

13 12.References a) Using evidence of outcomes to demonstrate compliance, Guidance for providers. September 2010 CQC _v3_00_what_is_outcome_evidence_for_external_publication.pdf b) A new system of registration, Provide Compliance Assessment, Guidance for providers, September 2010 CQC _v5_00_Guidance_on_Provider_Compliance_Assessment.pdf c) Guidance about compliance, Essential standards of quality and safety, March 2012 CQC d) Provider Compliance Assessment tools for Outcomes 1,2,4,5,6,7,8,9,20,11,12,13, 15,16,17 and 21 available at: we regulate/registered services/how wemonitor compliance/gathering information/provid e) Judgement Framework, How we judge providers compliance with the section 20 Regulations of the Health and Social Care Act 2008, April 2012, CQC ment_framework_for_publication.pdf f) F0 Preparing for CQC inspection, 2012 CQC g) Observation prompts and tools for Outcomes 1,4,5,7,9,12, 13 and 14, CQC available at: our staff/observation tools 13. Associated documentation RM01 Risk Management Strategy 13

14 Gateshead Health NHS Foundation Trust Quarterly governance declaration Appendix 1 Period Quarter Declaration to Head of Compliance CQC Board 1 April 30 June Qu1 30 June July 1 July 30 September Qu2 30 September October 1 October 31 December Qu3 31 December January 1 January 31 March Qu4 31 March April The divisions must confirm the compliance of all their services in relation to the Care Quality Commission s essential standards of quality and safety. The information documented for each of the 16 Outcomes of the Essential Standards must be discussed and agreed at the division s clinical governance meetings, where compliance will/will not be agreed. It is the responsibility of the divisional director/manager to sign off the division s declaration of compliance/non compliance Divisions which assess themselves as either Amber (partial compliance) or Red (non compliance) must submit a CQC action plan for each outcome assessed as Amber or Red. This action plan must detail the actions to be taken by the division to ensure that the next quarterly self assessment reflects compliance with these outcomes. Please sign one of the two declarations below. If you sign declaration 2 please ensure you also complete, agree and submit the CQC action plan. Declaration 1 The division confirms compliance with all the 16 Outcomes applicable to their services over the stated period and that sufficient plans are in place to ensure on going compliance. The Division confirms that the Statement of Purpose is accurate Discussed and agreed at the clinical governance meeting on (please give date) Divisional director/manager signature:.. On behalf of the division Print name: Declaration 2 For one or more of the 16 Outcomes the division cannot make Declaration 1 and has provided relevant details on the CQC action plan for each outcome assessed as Amber or Red in the period. The division confirms that all the other Outcomes have been met and that sufficient plans are in place to ensure on going compliance. The Division confirms that the Statement of Purpose if not accurate and the amended required are detailed overleaf. Discussed and agreed at the clinical governance meeting on (please state date). Divisional director/manager signature:.. On behalf of the division Print name:. 14

15 Amendments to the Statement of Purpose Please detail amendments under the appropriate regulated activity Division: Personal care Regulated activity Location Date of introduction of service Accommodation for persons who require nursing or personal care Accommodation for persons who require treatment for substance misuse Accommodation and nursing or personal care in the further education sector Treatment of disease, disorder or injury Assessment or medical treatment for persons detained under the Mental Health Act 1983 Surgical procedures Diagnositic and screening procedures Management of supply of blood and blood derived products Transport services, triage and medical advice provided remotely Maternity and midwifery services Termination of pregnancies Services in slimming clinics Nursing care Family planning services 15

16 Appendix 2 CQC Action Plan for (insert name of division) Must be completed for all CQC assessed as Amber (partial compliance) or Red (non compliance) Outcome Reason for partial/non compliance Actions to be taken Lead person Date to be completed Action plan agreed and signed off by (Divisional director/divisional manager): Date 16

17 Appendix 3 Submission Deadlines The dates below indicate the deadlines by which each step of the self assessment process should have been completed Step 1: Refresh of self assessment of compliance against all 16 CQC Outcomes; Step 2: Submission of Governance Declaration; Step 3: Submission of Clinical Governance meeting minutes for the period Step 4: Submission of CQC Action Plan if required Step 5: Submission of updated action plans Quarter 1: 30 June Quarter 2: 30 September Quarter 3: 31 December Quarter 4: 31 March 17

18 CQC Assurance Board Terms of Reference Appendix 4 1. Constitution & purpose The purpose of the CQC Assurance Board will be to act as a focal point for the management of compliance with the CQC regulations including registration, assessment process and visit arrangements. The CQC Assurance Board will make sure that robust systems are in place to manage effective CQC compliance and provide assurance to the Trust Board. The CQC Assurance Board reports to the PQRS Committee 2 Membership/attendance & quorum The membership of the CQC Assurance Board is: Director of Nursing, Midwifery and Quality Deputy Director of Nursing Head of Compliance and Assurance In addition to the core membership, the Board may co opt additional members as appropriate to enable it to undertake its role. The Director of Nursing, Midwifery & Quality shall assume the role of chair. The Deputy Director of Nursing shall assume the role of vice chair. Required quorum: there should be a minimum of 2 members 3 Meetings The CQC Assurance Board will meet on a quarterly basis which will be set and agreed by the committee although additional meetings may be convened as necessary in order to deal with urgent business. 4. Reporting arrangements to the PQRS The CQC Assurance Board will provide an annual report to the PQRS Committee with exception reporting where necessary. 5 Key responsibilities The key responsibilities of the CQC Assurance Board can be categorised as follows: Review quarterly self assessments from divisions Review action plans and monitor progress on action plans Inviting divisional directors/managers to attend meetings when necessary to report on actions in relation to gaps in assurance, any risk to compliance or failure to complete the process to declare compliance 18

19 Review and implement recommendations arising from CQC visits to the organisation Ensure compliance with the CQC regulations and registration Ensure identified risks are included and managed within the risk register 6 Monitoring & compliance The CQC Assurance Board will be monitored by the PQRS Committee through the annual report Date approved: Approved by: 19

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